2 Pmda Jobs

Regulatory Affairs Hiring Profile eCTD Specialist Experience Level: 3 to 6 Years Location: Remote Skills & Qualifications: 1. Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field. 2. Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the pharmaceutical or biotechnology industry. Role Overview: With 3 to 6 years of experience in regulatory affairs, this role requires expertise in eCTD submission software, strong knowledge of global regulatory standards, and the ability to troubleshoot and improve submission processes. The specialist will ensure compliance with evolving regulatory guidelines, provide support and training to teams, and collaborate with clients to meet submission requirements. Technical Skills: o Hands-on experience with eCTD submission software (e.g., Veeva Vault QMS, Lorenz DocuBridge, eCTDExpress etc.). o Strong knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) and eCTD formatting standards. o Familiarity with submission systems and document management processes. Soft Skills: Excellent attention to details and organizational skills. Strong communication skills, both written and verbal. Ability to work independently and collaboratively with clients. Problem-solving skills and the ability to troubleshoot technical issues related to client’s eCTD submissions. Key Responsibilities: Develop and manage our own eCTD software tool for the creation, validation, and submission of regulatory dossiers for all the regions. Stay up to date with the latest regulatory guidelines, standards, and requirements related to eCTD submissions. Continuously review and analyze regulatory trends and changes to ensure ongoing compliance and implementation of industry’s best practices. Conduct troubleshooting and resolve any issues related to eCTD submission formats and software functionality for our clients. Provide training and support to Development Team on the use of eCTD tools and best practices. Conduct quality checks on our eCTD tool and ensure they adhere to submission guidelines. Assist in making our eCTD software more robust, user friendly and easy to use. Keep up to date with new regulatory developments and technological advancements related to eCTD submissions and ensure team members are informed. Collaborate with clients to ensure all their submission-related requirements are met for successful filings.

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.