Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality standards for products or services. Author or review Ocugen quality standards, procedures, and work instructions. Participate in cross - functional teams to establish and enhance the quality systems and support for managing high levels of quality compliance at contract manufacturers. Build strategic relationships with CDMOs (Contract Development and Manufacturing Organization) within the Quality organization and participate in Business Review Meetings to ensure Quality issues are identified, managed, addressed, and escalated, as necessary. Establish, maintain , and monitor supplier files including Quality Agreements with CDMOs and directly related suppliers to the CDMOs. Responsible for the quality review and approval of master batch records, executed batch records, reports, protocols, analytical methods, change controls, investigations, OOS (Out of Specifications), OOT (Out of Trends), deviations, and CAPA for development, clinical and commercial processes, assess impact and provide quality oversight of implementation activities. Support RCA (Root Cause Analysis and associated tools) and product impact assessments for investigations resulting from deviations and OOS events. Oversee, review, and approve quality testing processes and identify gaps in testing. Oversee, review, and approve manufacturing processes and identify gaps in manufacturing. Overseeing, reviewing, and approving quality events and ensuring effectiveness is part of business improvements. Staying up to date with relevant laws and regulations to ensure compliance. Train other employees in quality standards and procedures and handle quality reports, documentation, and records. Collect and analyze QA data and prepare monthly and quarterly metrics regularly. Work with GMP vendors to ensure their quality and conduct vendor audit if necessary. Participate in internal audit program and followup on CAPA (Corrective and Preventive Actions) assigned to closure within the timeframe. Eliminating products that are not up to standards and finding the reasons for product problems Identify potential risks before they become a problem, focusing on root cause analysis and preventive action Identify opportunities for process improvements and efficiencies within the QA Operations function, driving continuous improvement initiatives. Qualifications: Bachelor' or Masters in Biology, Chemistry, or related fields. At least eight (8) years for BS and five (5) years for MS GMP experience with a focus on quality with substantial operational and GMP experience supporting Biologics/Vaccines/Cell and gene therapy products. At least five (5) years in roles of increasing management responsibility in a biopharmaceutical environment; at least two (2) years managing Phase 1-3 clinical trials. Prior experience and a broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. In-depth knowledge of the international regulatory landscape is preferred. In-depth knowledge of and ability to interpret and apply GMP EU, FDA (Food and Drug Administration), USP (United States Pharmacopeia), Phr. Eu., WHO, PMDA, and ICH regulations and guidelines. Excellent written, verbal, listening, and interpersonal communication skills. Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants, and contractors). Integrated Quality leader who can build strong collegial relationships cross-departmentally while effectively and courageously driving regulatory compliance. Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment. Proven background in GxP and GMP audit management, risk management, mitigation, and controls. Proficient in Veeva Vault systems (QualityDocs, Training, eQMS, RIM, etc.). Working conditions This position operates primarily in an office setting and may include 10% of travel. This position is in Hyderabad, INDIA (on-site). This position will work in US business hours. Physical requirements This is a sedentary role.

Job purpose : The Admin Assistant will be responsible for playing a crucial role in ensuring the smooth functioning of the office. He will be responsible for providing essential support to the office staff and maintaining a clean and organized workspace. Duties and responsibilities: Provide front-desk coverage by managing a busy, multiline phone system, greeting guests as they enter the office, managing incoming/outgoing mail and shipments, and maintaining an organized, clean office environment. Provide administrative support to senior leaders, including email correspondence and generation and distribution of memos, letters, spreadsheets, forms, and faxes Plan, organize, and schedule company meetings in the office, off-site, and via videoconference Coordinate domestic and international travel arrangements for employees Order and oversee office supplies and food deliveries for group meetings Organizing and maintaining physical and electronic files, creating filing systems, and managing databases. Scheduling and coordinating team meetings and events, preparing agendas, and taking meeting minutes. Assisting with bookkeeping, expense reporting, invoicing, and basic accounting tasks. Ordering and managing office supplies. To Ensuring the cleanliness and tidiness of all office areas. Facilitating and booking the meeting rooms. Maintain inwards and outwards register Reporting any maintenance or repair issues of AHU, Electricals and office equipment. Assisting in the coordination of office events and functions. Assisting Finance, IT & HR to perform their daily operations. Qualifications & Skills : Proven experience as an Administrative Assistant or Office Admin Assistant Bachelors degree Computer skills English written and verbal communication skills Strong time-management skills and multitasking ability Aptitude for learning new software and systems Working conditions: This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Job Purpose: We are seeking a Team lead for our Biometrics function in India, who can manage a team of Biostatistics, Statistical Programming & Clinical Data Management. This role serves as the single point of contact for the Biometrics team in India, coordinating activities across functions and supporting alignment with global development goals. Proven expertise in Biometrics and expected, a solid understanding of all three functional areas is essential for cross-functional coordination and communication with U.S. leadership. Duties and responsibilities: Oversee the day-to-day activities of the Biostatistics, Statistical Programming & Clinical Data Management teams in India. Coordinate with U.S.-based Biometrics leadership to align deliverables and timelines across global development programs. Support biostatistical leadership by overseeing the development and validation of Statistical Analysis Plans (SAPs), as well as generation of tables, listings, and figures (TLFs) for clinical study reports (CSRs). Supervise the creation and validation of SDTM and ADaM datasets in compliance with CDISC standards. Collaborate with Clinical Data Management leads (where applicable) to ensure effective Clinical Data Management practices and data quality. Ensure alignment of Biometrics activities with overall project goals, timelines, and regulatory requirements. Monitor workload, resourcing, and productivity across the India Biometrics team. Facilitate communication and integration across functional teams (Biostatistics, Statistical Programming & Clinical Data Management). Mentor and support the development of team members across both disciplines. Stay current with industry standards and regulatory expectations in Biostatistics, Statistical Programming , CDISC, and Clinical Data Management practices. Qualifications: Masters degree in Biostatistics, Statistics, Clinical Data Science, Life Sciences, or a related field. 15+ years of experience in the pharmaceutical, biotechnology, or CRO industry within biostatistics, statistical programming, and/or Clinical Data Management. Strong working knowledge of clinical trial processes and relevant regulatory requirements (e.g., GCP, CDISC, BLA/NDA submissions). Hands-on expertise Biometrics with all three functions (Biostatistics, Statistical Programming & Clinical Data Management). Ability to lead and manage cross-functional technical teams. Strong project management, problem-solving, and interpersonal communication skills. Proficiency in relevant tools and platforms (e.g., SAS, R, EDC systems, CDMS, Veeva eTMF, Quality Docs, and eQMS platforms). Experience working in a global team structure and across time zones. Proven track record of leading and managing cross-functional biometrics teams, with experience in overseeing the development and validation of statistical analysis plans and clinical study reports. Experience with CDISC standards (SDTM and ADaM) and proficiency in statistical programming languages (e.g., SAS, R). Familiarity with electronic data capture (EDC) systems and Clinical Data Management systems, with a strong understanding of data integrity and quality practices. Demonstrated ability to manage multiple projects simultaneously in a fast-paced environment, with excellent organizational and problem-solving skills. Strong interpersonal and communication skills, with the ability to collaborate effectively with global teams and senior leadership. Commitment to continuous professional development and staying current with industry trends and best practices. Experience with Microsoft-based applications and ability to learn internal applications/systems, including Veeva platforms such as Quality Docs, eTMF, and CDMS. Experience with eQMS systems is a plus. Working conditions: This position operates in an office setting. The job may require an incumbent to be available outside of these hours to handle priority business needs. Physical requirements: This is a largely sedentary role.

Job Description : As a biotechnology trailblazer, we're dedicated to discovering, developing, and commercializing cutting-edge gene and cell therapies, and biologics to transform global healthcare. If you're ready to be part of a team that's shaping the future of medicine and making a profound impact on patient lives worldwide, join Ocugen and well rewrite the future of healthcare together. Job purpose : The Statistical Programmer will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods and generation of accurate and reproducible results through error- free statistical programming in SAS, R and/or other programming languages. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs. Duties and responsibilities : SAS Programming : You'll utilize advanced SAS programming skills to analyze and report clinical trial data (both safety and efficacy). CDISC Standards : Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents : You'll create and review submission documents and electronic case report forms (eCRTs). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group. Qualifications : MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field Typically requires a minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry. Expertise: Familiarity with statistical principles, CDISC data, and standards. Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus SAS, (Base, Stat, Macro, graph); SAS certificates a plus Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. This is a largely sedentary role.

Job purpose : The Clinical Database Programmer is a key member of Clinical Biometrics team. This individual will be responsible for providing database services including database design, creation, and validation to collect data for research, development, and/or marketed product. The individual should be able to ensure accurate data collection from electronic systems through error-free programming. This individual will work closely with the Biostatistics and Data Management team as well as other Ocugen team members to execute the statistical and data needs of the clinical studies. Duties and responsibilities : Collaborates with other team members to define database requirements . Involves in programming, validation of standard and study-specific electronic Case Report Forms (eCRFs). Troubleshoots and resolves database issues timely. Designs, implements and maintaining databases or collaborates on implementation and collection of data supporting research protocols. Provides database consultation for research programs. Collaborates on development of database specifications, data management plans, data transfer specifications, data review specifications and/or data quality review plan specifications Develops edit checks, QC, and validation reports to ensure quality data. Provides input to project timelines and ensures that project timelines for database deliverables are met. Ensures that project tasks are completed with acceptable quality. Ensuring data integrity ,security and availability. Perform database back ups and recovery. Attends team meetings. Additional tasks and projects as requested. Qualifications: BS/BA degree in Computer Science, or work-related experience. 5-8 years related experience. Experience with relational databases and Programming. Experience with developing eDC databases (e.g. Veeva Vault or RAVE), IRT systems (including randomization), and ePRO applications for data collection. Database programming language experience (e.g. SQL, PHP). Website programming language experience is a plus (e.g. HTML, Javascript) Statistical programming language experience is a plus (e.g. SAS, R, Python). Working knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies. Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Working conditions: This position operates in an office and/or remote setting. Job may additionally require incumbent to be available outside of regular 9-5 hours to handle priority business needs. Physical requirements: This is a largely sedentary role.

Job purpose: As part of the Ocugen team, the GxP Systems Specialist will implement and manage the Ocugen Veeva vault and other GxP applications to meet regulatory requirements and business needs. The ideal candidate should bring experience working in enterprise application environments in life sciences with the ability to manage multiple projects across different functions. The candidate should also be experienced as a technical lead for IT (Information Technology) projects. Duties and responsibilities: Accountable for implementation/delivery of Veeva applications to meet Ocugen business needs with a focus on regulated functions: Serve as a subject matter expert in business and system administration with extensive hands-on experience configuring Veeva Vault platforms, including Quality, QMS, Training, Clinical, and RIM applications. Evaluate Veeva general releases, conduct assessments/proof of concepts (POCs), and develop business cases for implementing new enhancements or configurations to align with enterprise needs. Lead and oversee change controls, manage system deviations, and drive continuous improvement initiatives. Ensure all activities are performed in accordance with defined GxP processes and are appropriately documented to maintain compliance. Ensure critical system operations activitiessuch as access management, periodic reviews, configuration updates, and data integrity monitoring—are performed in compliance with established GxP procedures and operational standards. Support change management initiatives to ensure effective planning, communication, and adoption of new systems and processes. Liaise with computer system vendors, Quality, and business stakeholders to coordinate implementation activities, applying vendor management best practices. Help define project scope and deliverables to support business goals in collaboration with senior management stakeholders. Identify opportunities for innovation and process optimization based on evolving client and regulatory requirements Work with the business to develop and document system and user requirements aligned with GxP principles and 21 CFR Part 11 compliance. Define and oversee documentation of configuration and design specifications. Contribute to the authoring and execution of implementation plans, qualification tests, and computerized system validation (CSV) documentation. Develop and maintain CSV standards, procedures, and work instructions to ensure consistent execution and regulatory compliance. Provide support for internal audits and regulatory inspections by ensuring system readiness, documentation accuracy, and timely response to findings or queries. Provide support during U.S. business hours, as required, to ensure incident/issue system resolution across global teams. Management Of GxP Systems Lifecycle Management of system access and permissions. Perform change management activities. Design solutions and manage configuration. Liaise with users to resolve issues. Create reports based on defined requirements. Maintain system documentation. Build systems reports and dashboards. Propose standardization and harmonized approach for configuration. Manage major and minor release including risk-based approach for validation and implementation. Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization. Qualifications: Qualifications include: Bachelor’s degree in computer science or technology with at least 5+ years’ direct experience working with Veeva Vault Technologies implementation and establishing enduring Governance to drive strategic Product Roadmap Deliveries. Experience with the Veeva Vault Development Platform, including QDocs, Training, RIM, QMS, CTMS and cross-domain integrations. Experience and knowledge of quality and regulatory business processes. Direct hands-on experience implementing GxP computerized systems and maintaining validated state. Strong process improvement skills and orientation. Must have proven business and technology skills in successfully providing a customer-oriented technology solutions environment. Proven strong communication skills in interacting with users and technical communities. Ability to communicate ideas in both technical and user-friendly language. Collaborative working approach. Computer Skills: Certified Veeva System Administrator - Required. Veeva Vault Owner/System Administration Experience (Quality QMS (Quality Management System), Quality QualityDocs and Training, RIMS/Submissions, Clinical, Safety, Station Manager, Vault Mobile, etc.) Experience with Other Regulated Applications would be an asset Database and computer networking knowledge Experience working on SaaS (Software as a Service) systems Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethics; Upholds organizational values. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction. Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information. Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts team success above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit, Shares expertise with others. Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Change the approach or method to best fit the situation. Able to deal with frequent changes, delays, or unexpected events. Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to build knowledge and skills continuously; Shares expertise with others. Dependability - Follows instructions, responds to management direction, takes responsibility for own actions, keeps commitments, commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies the appropriate person with an alternate plan. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget. Working conditions: This position operates primarily in an office setting and may include 10% of travel. Physical requirements : This is a largely sedentary role.

Job purpose: As part of the Ocugen team, the GxP Systems Specialist will implement and manage the Ocugen Veeva vault and other GxP applications to meet regulatory requirements and business needs. The ideal candidate should bring experience working in enterprise application environments in life sciences with the ability to manage multiple projects across different functions. The candidate should also be experienced as a technical lead for IT (Information Technology) projects. Duties and responsibilities: Accountable for implementation/delivery of Veeva applications to meet Ocugen business needs with a focus on regulated functions: Serve as a subject matter expert in business and system administration with extensive hands-on experience configuring Veeva Vault platforms, including Quality, QMS, Training, Clinical, and RIM applications. Evaluate Veeva general releases, conduct assessments/proof of concepts (POCs), and develop business cases for implementing new enhancements or configurations to align with enterprise needs. Lead and oversee change controls, manage system deviations, and drive continuous improvement initiatives. Ensure all activities are performed in accordance with defined GxP processes and are appropriately documented to maintain compliance. Ensure critical system operations activitiessuch as access management, periodic reviews, configuration updates, and data integrity monitoring—are performed in compliance with established GxP procedures and operational standards. Support change management initiatives to ensure effective planning, communication, and adoption of new systems and processes. Liaise with computer system vendors, Quality, and business stakeholders to coordinate implementation activities, applying vendor management best practices. Help define project scope and deliverables to support business goals in collaboration with senior management stakeholders. Identify opportunities for innovation and process optimization based on evolving client and regulatory requirements Work with the business to develop and document system and user requirements aligned with GxP principles and 21 CFR Part 11 compliance. Define and oversee documentation of configuration and design specifications. Contribute to the authoring and execution of implementation plans, qualification tests, and computerized system validation (CSV) documentation. Develop and maintain CSV standards, procedures, and work instructions to ensure consistent execution and regulatory compliance. Provide support for internal audits and regulatory inspections by ensuring system readiness, documentation accuracy, and timely response to findings or queries. Provide support during U.S. business hours, as required, to ensure incident/issue system resolution across global teams. Management Of GxP Systems Lifecycle Management of system access and permissions. Perform change management activities. Design solutions and manage configuration. Liaise with users to resolve issues. Create reports based on defined requirements. Maintain system documentation. Build systems reports and dashboards. Propose standardization and harmonized approach for configuration. Manage major and minor release including risk-based approach for validation and implementation. Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization. Qualifications: Qualifications include: Bachelor’s degree in computer science or technology with at least 5+ years’ direct experience working with Veeva Vault Technologies implementation and establishing enduring Governance to drive strategic Product Roadmap Deliveries. Experience with the Veeva Vault Development Platform, including QDocs, Training, RIM, QMS, CTMS and cross-domain integrations. Experience and knowledge of quality and regulatory business processes. Direct hands-on experience implementing GxP computerized systems and maintaining validated state. Strong process improvement skills and orientation. Must have proven business and technology skills in successfully providing a customer-oriented technology solutions environment. Proven strong communication skills in interacting with users and technical communities. Ability to communicate ideas in both technical and user-friendly language. Collaborative working approach. Computer Skills: Certified Veeva System Administrator - Required. Veeva Vault Owner/System Administration Experience (Quality QMS (Quality Management System), Quality QualityDocs and Training, RIMS/Submissions, Clinical, Safety, Station Manager, Vault Mobile, etc.) Experience with Other Regulated Applications would be an asset Database and computer networking knowledge Experience working on SaaS (Software as a Service) systems Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethics; Upholds organizational values. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction. Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information. Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts team success above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit, Shares expertise with others. Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Change the approach or method to best fit the situation. Able to deal with frequent changes, delays, or unexpected events. Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to build knowledge and skills continuously; Shares expertise with others. Dependability - Follows instructions, responds to management direction, takes responsibility for own actions, keeps commitments, commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies the appropriate person with an alternate plan. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget. Working conditions: This position operates primarily in an office setting and may include 10% of travel. Physical requirements : This is a largely sedentary role.

Job Purpose Ocugen Inc, is seeking a Financial Reporting Analyst reporting to the Director of SEC Reporting. This role will play a key role in various elements of the Companys SEC Reporting/Technical Accounting functions. The ideal candidate will have a working knowledge of SEC regulations, U.S. GAAP accounting principles, and requirements of financial statements and related disclosures, along with the ability to effectively research accounting topics. Candidate will interface regularly with other key members of the corporate accounting, finance, legal, human resources and the external auditors. Responsibilities Prepare accurate and timely financial disclosures for SEC filings, including Forms 10-K and 10-Q. Support the development of financial content for Investor Relations communications, including 8-Ks, earnings call scripts, and investor presentations. Leverage automation tools to streamline data gathering and enhance reporting workflows. Analyze complex and non-routine transactions, providing insight into financial and operational impacts. Research and interpret U.S. GAAP and SEC accounting guidance; draft technical accounting memos to support conclusions. Contribute to valuation activities, including the assessment and reporting of stock-based compensation. Support Sarbanes-Oxley (SOX) compliance efforts by executing and maintaining internal controls over financial reporting. Collaborate cross-functionally with internal stakeholders to ensure accurate, compliant, and insightful financial reporting. Required Experience and Qualifications Bachelors degree in accounting. Minimum of 4 years of experience in public accounting or a related industry role. Strong understanding and interest in applying U.S. GAAP and SEC regulations to real-world scenarios. Highly detail-oriented, organized, and able to manage multiple priorities effectively. Excellent written and verbal communication skills. Proven ability to work collaboratively across teams and build strong working relationships. Strong analytical and problem-solving skills with the ability to think independently. Comfortable operating in a fast-paced and dynamic work environment. Preferred Qualifications Experience in SEC financial reporting. Background in Big 4 accounting firm or experience within a public company environment. Familiarity with NetSuite general ledger system and/or Workiva reporting tools. Working conditions This position operates in an office setting. The job may require an incumbent to be available outside of these hours to handle priority business needs.

Job Purpose Responsible for the design and oversight of safety pharmacology, exploration, and GLP-compliant toxicology studies. Manage multiple projects efficiently across various stages of discovery, preclinical, and clinical development. Contribute to the preparation and review of regulatory submissions and engage with regulatory authorities and cross-functional asset teams This position is located in Hyderabad, Telangana, India. Duties And Responsibilities : Preclinical Pharmacology Design, supervise, and interpret in vivo efficacy studies using a range of disease models. Provide scientific and technical oversight for preclinical pharmacology programs. Prepare study proposals, budgets, and timelines. Lead and mentor scientific staff supporting pharmacology operations. Analyze and compile data, ensuring GxP-compliant documentation and reporting. Contribute to the drafting and revision of regulatory documents including investigator brochures and study reports. Toxicology & Safety Assessment Lead toxicology strategy across discovery, preclinical, and clinical development phases, with an emphasis on human risk assessment and elucidation of toxicity mechanisms for novel therapeutic targets. Act as the primary liaison with CROs, overseeing study conduct and coordinating with technical, veterinary, and scientific personnel. Manage outsourced GLP and non-GLP studies to ensure adherence to protocols, regulatory requirements, safety standards, and SOPs. Integrate expertise in toxicology, pharmacology, ADME, and regulatory guidelines to design robust nonclinical safety assessment strategies. Identify and apply innovative approaches to streamline and accelerate nonclinical development timelines. Critically evaluate study protocols, data sets, and reports to ensure scientific validity and regulatory compliance. Regulatory and Cross-Functional Support Lead or support the preparation of regulatory submissions (e.g., IND, CTA, IB, NDA, BLA). Develop and implement program-specific toxicology plans in collaboration with cross-functional project teams to support compound progression. Represent toxicology and safety pharmacology functions on multidisciplinary project teams. Author and review toxicology reports and regulatory documents; contribute to regulatory submissions and interactions with global health authorities. Represent toxicology function on multidisciplinary teams supporting all stages of drug development. Contributes to the development of high-quality regulatory submissions for global clinical trials and marketing authorizations. Communicate findings and recommendations effectively to project teams and senior leadership. Qualifications and skills : Ph.D. in Toxicology, Pharmacology, or a related field. Strong knowledge of regulatory guidelines (ICH, FDA, EMA) and GxP standards. Minimum 5 years of relevant industry experience in preclinical drug development, or equivalent regulatory experience. Proven experience in designing, managing, and interpreting non-clinical safety and efficacy studies. Demonstrated ability to prepare and review nonclinical sections of regulatory documents like CTA, IND, IB, NDA, BLA, etc. Effective leadership, project management, and cross-functional collaboration skills. Willingness to travel as needed. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA. Working conditions: This position operates primarily in an office setting and may include 10% of travel. Mandatory onsite presence is required. Physical Requirements: This is a largely sedentary role.