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2.0 - 4.0 years
8 - 12 Lacs
Pune
Work from Office
Description. Sr Regulatory Associate (CMC). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA). Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.. Can support change control assessment and impact assessments for global markets.. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.. Assists in training and mentoring of team members depending upon project requirements. Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.. Timely sensitization /escalation within team to maintain compliance and adherence to timelines.. Secondary. Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases. Hands on experience of RIMS/VEEVA vault.. Excellent written and verbal communication skills. Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs. Good communication skills clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings. Qualifications. Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less
Posted 3 days ago
1.0 - 6.0 years
2 - 7 Lacs
Ahmedabad
Work from Office
Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier compilation for ACTD & CTD is mandatory. Coordination with the external stakeholders for the preparation of the regulatory documents. To be responsible for the Life cycle management of assigned products. Should have experience for Life cycle management and license Maintenance. Should have good knowledge for recent guidelines, websites and trends of Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Desired Candidate Profile Candidate must have good knowledge of working in Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Perks and Benefits Best in industry. Immediate Joiners preferred
Posted 4 days ago
8.0 - 13.0 years
20 - 35 Lacs
Gurugram
Hybrid
Exp. in Trade & Transaction Regulatory Reporting in-depth knowledge of the Broadridge regulatory reporting tool and extensive exp. in regulatory reporting across various jurisdictions including EMIR, CFTC, ASIC, and HKMA etc.Utilize the Broadridge Required Candidate profile •Lead and manage the regulatory reporting processes for trade and transaction reporting.• Drive transformation and improvement initiatives in the current reporting processes.• Ensure compliance
Posted 4 days ago
1.0 - 2.0 years
3 - 3 Lacs
Ahmedabad
Work from Office
Roles & Responsibilities: 1. Product Registration: Handle the registration of products under FDCA (Food and Drugs Control Administration) for necessary approvals. 2. Label Claim Verification: Coordinate with the Formulation & Development team to confirm and validate claims mentioned on product labels and the regulatory classification of each product. 3. Artwork Coordination: Work closely with the sales team to ensure that product artworks (for existing and new products) meet all relevant regulatory requirements. 4. Renewals & Compliance: Manage the timely renewal of product approvals under applicable regulatory bodies, maintaining full compliance throughout the product lifecycle. Qualifications: 1. Bachelors or master’s degree in pharmacy , chemistry, or a related field. 2. 1–2 years of experience in regulatory affairs (preferably in cosmetics, personal care, or pharma). 3. Good knowledge of FDCA and other relevant cosmetic product regulations. 4. Strong communication, coordination, and documentation skills. 5. Detail-oriented with a proactive approach to compliance and deadlines.
Posted 4 days ago
6.0 - 11.0 years
8 - 13 Lacs
Pune
Work from Office
Job Title: IT Regulatory Reporting Governance Coordinator Corporate Title: AVP Role Description The IT Regulatory Reporting Governance team provides an essential 24x7 service to manage IT regulatory reportable events related to IT incidents. The team is responsible for coordinating with IT stakeholders to assess, classify and ensure timely and accurate reporting to regulators. The team operates with a high level of expertise and coordination to manage the complex regulatory landscape effectively. A significant portion of the team's work involves ensuring compliance with the European Supervisory Authority (ESA) Digital Operational Readiness Act (DORA), which sets a new standard for regulatory reporting. However, the team's scope extends beyond DORA to include support for additional regulatory requirements including but not exhaustive of MAS, FSS, US Regulators, US Fed, FSA, HKMA. The IT Regulatory Reporting Governance Coordinator will play a vital role in supporting the operational execution of the IT Regulatory Reporting process. This position involves assessing and classifying incident data to identify events that may require regulatory reporting, as well as preparing and submitting accurate regulatory reports. Additionally, the role includes providing oversight and conducting four-eye checks to ensure the accuracy and completeness of these reports. The IT Regulatory Reporting Governance Coordinator will also be responsible for identifying potential service improvements and associated risks, contributing to the overall efficiency and effectiveness of the reporting process. This role is integral to ensuring Deutsche Bank meets its regulatory obligations efficiently and effectively, while also supporting continuous improvement and risk management within the regulatory reporting process. Your key responsibilities Executing the regulatory reporting process in adherence with all Deutsche Bank charters, policies, key operating procedures, and key operating documents. Performing initial assessment and classification of data to support the identification of potential regulatory reportable events and preparing draft reports. Preparation and responsibility for the submission of accurate regulatory reports to the Regulator. Oversight/Four-eye checks to ensure the accuracy and completeness of regulatory reports. Identifying risks related to regulatory compliance, support processes and controls, ensuring escalation where required. Contributing to Continual Service Improvements. Undertaking reporting activities to support monthly service reports. Participating in OnCall/Weekend/Bank Holiday working where required. Your skills and experience Essential - Excellent communication skills, both written and verbal. Essential - Effective team collaboration and interpersonal skills. Essential - Ability to work well under pressure and meet tight deadlines. Essential - Demonstrable experience in financial reporting, preferably within a regulated industry. Essential - Ability to extract and analyse data with attention to detail to identify if Regulatory Reporting triggers have been reached. Essential - An ability to navigate ambiguity Desired People Management experience. Desired - An understanding of Incident & Problem Management processes. Desired - Awareness of IT regulations applicable to financial institutions.
Posted 6 days ago
6.0 - 7.0 years
27 - 42 Lacs
Mumbai
Work from Office
Job Summary The TM-Pharmacovigilance role involves ensuring the safety and efficacy of pharmaceutical products through vigilant monitoring and analysis. With a focus on regulatory intelligence the candidate will contribute to maintaining compliance and enhancing customer service. This hybrid role requires rotational shifts and proficiency in English with no travel obligations. Responsibilities Monitor and analyze adverse drug reactions to ensure patient safety and product efficacy. Collaborate with cross-functional teams to gather and interpret regulatory intelligence data. Provide expert guidance on pharmacovigilance processes to enhance customer service experiences. Develop and implement strategies for effective risk management and mitigation. Ensure compliance with global regulatory standards and guidelines in pharmacovigilance activities. Oversee the preparation and submission of regulatory reports and documentation. Conduct thorough research to support the development of new pharmacovigilance methodologies. Facilitate communication between stakeholders to ensure seamless regulatory affairs processes. Utilize advanced analytical tools to assess and improve pharmacovigilance systems. Lead initiatives to optimize research and development efforts in drug safety. Support the integration of regulatory intelligence into strategic planning and decision-making. Drive continuous improvement in pharmacovigilance practices to benefit public health. Maintain up-to-date knowledge of industry trends and regulatory changes. Qualifications Possess strong expertise in customer service within the pharmacovigilance domain. Demonstrate proficiency in regulatory intelligence and its application in drug safety. Have experience in regulatory affairs and research and development as a nice to have skill. Exhibit excellent communication skills in English both written and spoken. Show ability to work effectively in a hybrid work model with rotational shifts. Display a commitment to maintaining high standards of compliance and safety. Bring a proactive approach to problem-solving and process improvement. Certifications Required Certified Pharmacovigilance Professional Regulatory Affairs Certification - B.Pharm/M.Pharm
Posted 1 week ago
15.0 - 20.0 years
25 - 35 Lacs
Vapi, Ahmedabad, Mumbai (All Areas)
Work from Office
Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.
Posted 1 week ago
2.0 - 4.0 years
10 - 13 Lacs
Gurugram
Hybrid
urpose: To support the Legal & Compliance team in managing legal advisory, corporate governance, and regulatory compliance. Qualifications: Essential: Bachelor of Law (English Medium) Preferred: Qualified Company Secretary Experience: Minimum 3 years in corporate legal advisory or law firm Key Skills: Strong drafting and legal documentation skills Excellent oral & written communication Knowledge of corporate laws and governance Attention to detail, time management, and organizational skills Proficient in MS Office (Word, Excel, PowerPoint) Ability to handle confidential information with discretion Key Responsibilities: Draft, review, and negotiate legal documents, contracts, and policies Conduct legal research on company law and applicable regulations Assist in preparing board packs, compliance trackers, and regulatory filings Maintain statutory records and ensure timely compliance Liaise with external legal counsel and regulatory bodies Provide administrative support to the Legal Head
Posted 1 week ago
3.0 - 8.0 years
4 - 9 Lacs
Chennai
Work from Office
Job Purpose: This role is responsible for the development and design of methodologies and standards for review activities across the products in alignment with Compliance Risk Framework. Testing, validation, and documentation of review activities for new and existing products and controls according to standards and other applicable policies. Overseeing the effective implementation of testing observations, tracking and closure of all compliance requirements by coordinating with respective functions. Owning projects and tracking, preparing Compliance dashboards for reviews and implement action points, building and maintaining healthy business relations with external and internal customers. Key Responsibilities Functional Responsibilities Outcome of Risk assessment Compliance control point shall be defined, and testing will be carried out. Planning and execution of Compliance testing. Establish and maintain comprehensive compliance testing programs to identify, assess, and highlight compliance risks. Monitor and test compliance by performing sufficient and representative Compliance testing and result of such compliance testing shall be reported to the Senior Management. Track Compliance testing observation open points, coordinate with respective team for implementation and track until closure of testing. Responsible for executing the proposed Compliance projects. Support the reporting manager on regulatory reporting. Support the reporting manager in handling / preparedness of RBI inspection like Co-ordinate with respective team, data collection, review the documents and Finalization of RBI datas, day to day RBI Correspondences, returns filing and circulation of Compliance MIS. Job Requirements Qualifications: CA / CMA /Any graduate Experience 2 - 5 Years relevant experience in Compliance / Internal audit / Internal Control from Banks / NBFC s / Consulting Functional Competencies Drive and initiative, strong commitment, ability to take ownership, Analytical acumen, eye for details, Smart thinkingHigh level of integrity, professionalism, and attention to detailExp in handling various projects Behavioral Competencies Strong Analytical, Interpersonal and Convincing skillsStrong communication and interpersonal skillsProblem solving and decision-making skillsPeople management and networking skills
Posted 1 week ago
3.0 - 7.0 years
6 - 12 Lacs
Gurugram
Work from Office
Role & responsibilities: The candidates Core Profile would be Handling RBI Compliances, so 3-5 years RBI Experience is must. Required Experience: RBI Ensuring various Compliances under Master Direction of Reserve Bank of India for NBFCs and amended Rules thereon. Dealing with various circulars as issued by RBI i.e. Scale Based Regulations, Outsourcing Guidelines etc. Dealing with Fraud Guidelines and filing returns of fraud i.e. Monthly Certificate of Fraud, FMR-1, FMR-3 & FMR-4 (XBRL / CIMS Format) Taking prior approval from RBI for appointment of Directors & other matters Handling Select scope inspection from RBI and drafting of requisite replies for the inspection letter Working Knowledge of Inspection of RBI Preparation & filing of various monthly, quarterly, half yearly & annually returns of RBI i.e. Returns of Short-Term Foreign Currency Borrowing, quarterly overseas borrowing return, Statement of Change of Directors & Auditor Report etc. LEI obtaining and yearly renewal. Filing Return of Digital Lending Apps (DLA Return) Filing of Entity Master Data through Single Master Form (SMF-FIRMS) with the RBI. Filing of application for registration of a Company as NBFC with the Reserve Bank of India. Preference for additional experience: Companies Act & SEBI Compliances Compliance of relevant provisions of the SEBI Listing Regulations including LODR, Insider Trading, SAST, ICDR. Ensuring various listing compliances of Equity & Debt i.e. monthly, quarterly, half yearly, annually, event based etc. Listing of Non-Convertible Debentures (NCD) Handling Related Party Transactions (RPTs), Corporate Social Responsibility (CSR) Compliances Preparation of Notice, Agenda and Minutes of Meetings of Board and Committees. Assistance in Convening Board Meetings and General Meetings of the Company. Maintaining the Statutory Register and Records. Compliance of various applicable provisions of Companies Act, 2013 on a Public Limited Company ESOP Policy Drafting & ESOP Compliances. Drafting of various policies of the Company. Preparation of Annual Return, Board Report and Annual Report of the Company. Filing of various E-Forms with the Registrar of Companies (ROC). Filing of return of FLA, FCGPR, FCTRS and various other returns under FEMA Regulations Liaison & Co-ordination Liaison with Government Officials of Ministry of Corporate Affairs, Registrar of Companies, Stock Exchanges, Depositories & RBI Liaison with Counsels, RTAs wrt Share related matters.
Posted 2 weeks ago
10.0 - 15.0 years
20 - 25 Lacs
Vapi, Ahmedabad, Mumbai (All Areas)
Work from Office
Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.
Posted 2 weeks ago
5.0 - 8.0 years
18 - 20 Lacs
Mumbai, Mumbai Suburban, Mumbai (All Areas)
Work from Office
We are seeking an experienced and proactive professional to join our Compliance team as Assistant Vice President (AVP). The AVP Compliance will be responsible for providing oversight and support in execution of various compliance activities, ensuring full adherence to applicable regulatory requirements. Key Responsibilities: 1. Regulatory Reporting and Oversight: Prepare / Review and validate periodic reports prepared for submission to regulatory authorities. Monitor regulatory timelines and ensure adherence to filing deadlines. Provide guidance to junior team members and coordinate cross-departmental inputs. 2. Compliance Monitoring Tool Management: Oversee the maintenance, enhancement and effective usage of the compliance monitoring tool. Ensure timely tracking and closure of regulatory obligations. 3. Support on Board and Committee Meetings: Preparation of agenda, presentation, and notes for Board and Board Committee meetings. Ensure all compliance-related matters are captured and documented accurately. Maintain records and minutes as per regulatory and internal requirements. 4. Reporting to Parent company and other compliance activities Submission of Certificates, Dashboards and other reports to the Parent Company Approve marketing and promotional content from a regulatory compliance standpoint. Handling Internal audit requirements. 5. General Compliance Oversight: Provide mentoring to junior compliance team members and support their deliverables. Coordinate with senior stakeholders to resolve compliance issues and strengthen internal governance. Qualifications & Experience: Graduate/Postgraduate in Law, Commerce, Finance, or related field. 5–8 years of relevant experience in compliance within the BFSI/NBFC sector. Strong understanding of RBI Master Directions, SEBI regulations, and other relevant compliance frameworks.
Posted 3 weeks ago
5.0 - 7.0 years
6 - 7 Lacs
Mumbai
Work from Office
Accounting & Analysis, Audit & Compliance, FCRA & Regulatory Work, Donor Management & Reporting. Please visit the link for a detailed Job Description - https://shorturl.at/2OI9F Perks and benefits PF + Health Insurance + Paid Time Off
Posted 3 weeks ago
3.0 - 8.0 years
3 - 5 Lacs
Bengaluru
Remote
Job Description: Assist and manage (as applicable) in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components. Support and delivery of submission ready packages to agreed timelines and management of information required. Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications. Prior experience in Veeva vault is preferable. Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables. Develop research skills relevant information, regulations, and guidance from different regulatory agencies. Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination. Assist in the preparation of agendas, presentations, and other supporting materials for various meetings. Contribute to the development and improvement of related business processes. Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required. Ensure the learning from own projects are shared with other colleagues/within the functions. Skills Required : Proficient/Good working experience in Veeva tool. Should have very good technical understanding of the tool Good Knowledge Documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market.
Posted 3 weeks ago
3.0 - 8.0 years
9 - 13 Lacs
Bengaluru
Work from Office
The role requires considerable experience in Regulatory Compliance with experience reading, interpreting, tracking, and assisting in administrating internal and external guidelines to comply with all regulatory requirements. Must be adept in the preparation of MIS Reports / Dashboards using Advanced Excel Spreadsheets. The individual will be responsible for maintaining repositories, preparing monthly and ad-hoc reports Role & responsibilities - Strict control over Organizational Data Repository related to Regulatory Compliance for Preparation of Regulatory reports, Dashboards, Presentations. - Proficient in Regulatory Circulars/Guidelines' Interpretation. Assisting the Compliance Officer in gap analysis on new Regulatory Guidelines to ensure implementation. - Collaborate with various departments for comprehensive Regulatory Compliance management and keep the Compliance Officer updated on any shortcomings to be addressed. - Hands-on experience in assisting the Compliance Officer in preparing the periodical and ad-hoc Regulatory Reports sought by SEBI/RBI. - Ensure compliance of staff to policies such as Staff Accountability Policy, Trading Policy, Code of Conduct, etc., and maintain related documentary evidence. - Answering employee queries relating to compliance-related matters Skills and Competencies: - Domain Knowledge of Regulatory Compliance - Strong understanding of legal and regulatory requirements in the financial services industry - specifically in credit rating agencies/banks/NBFCs. - Strong understanding of regulatory requirements (SEBI, RBI, NSDL) and relevant industry standards. Familiarity with regulatory portals such as NSDL etc. - Proficient in MS Office. Especially an Excel expert with Advanced Excel skills, and the ability to analyze complex data and present meaningful reports to senior management. - Team Player with the ability to execute compliance projects focused on regulatory compliance. Provides necessary support to the Compliance Officer to implement compliance and risk management policies. - Strong analytical, problem-solving, verbal, and written communication skills. Attention to detail. Job Location: Bangalore Education: Bachelor's degree in Finance, or and Law, or a related field; Post Graduation and any additional certifications in these fields will be an added advantage. Experience: 3+ years of relevant experience in the Compliance division in financial services institutions such as credit rating agencies/banks/NBFCs.
Posted 3 weeks ago
2.0 - 7.0 years
5 - 13 Lacs
Noida, Ghaziabad, Delhi / NCR
Work from Office
Role & responsibilities Function -Compliance Location -Delhi NCR Role -Deputy Manager / Manager - Compliance Reporting -Chief Compliance Officer Key Result Areas • Making submission of NHB/Returns. • Doing impact analysis of new guidelines from RBI/NHB • Dissemination of new guidelines and relevant actionable to relevant stakeholder and ensure implementation of same in the organization. • Review of various documents including policies, process notes, forms, etc. to ensure that they are in compliance with applicable regulatory norms and closure with relevant stakeholders. • Compliance monitoring through various checklist. • Preparation of MIS, reports for the Compliance Function. • To review Compliance policy / manual periodically. • Regular review with respect to implementation of regulatory requirements set-out in polices /process, managed by respective stake holders/departments. • Dealing with regulatory communications and coordination with relevant stakeholders. • Keep updating regarding latest amendments in the applicable regulations/ guidelines etc. as posted on RBI/ NHB websites. • Compile and prepare the relevant data as and when required by Regulator. • Coordinating with other teams/ stakeholders for all the necessary data/ information/ documents as required for execution and monitoring of Compliance framework. • Coordinating with all External (Auditors/consultant) stakeholders to all matters related to Compliance function. • Track all the issues of non-compliance against other HFCs and does a root cause analysis and implementation for the same. • Taking remedial action against the adverse comments received from NHB/RBI i.e. the comments are addressed within the due timelines Required Skills • Candidate from HFC/NBFC is preferred • High degree of professional ethics, integrity and gravitas • Exceptional interpersonal and communication skills
Posted 1 month ago
5.0 - 10.0 years
5 - 11 Lacs
Gurugram
Work from Office
work: Expert in regulatory compliance Oversee RBI reporting, guidelines adherence & risk management Manage government affairs, liaison & relations FEMA expertise Escrow & Consortium Knowledge Biz Development & Management Communication skills Annual bonus Health insurance
Posted 1 month ago
6.0 - 11.0 years
15 - 30 Lacs
Gurugram
Work from Office
Hiring for a Startup Company in Gurgaon ( By a renowned US Investor ) Hiring for Fund Accounting Skills Required - Fund Accounting, & Private equity funds, NAV Calculations, Waterfall, Regulatory Reporting, Hedge Funds, Capital Calls, Geneva Required Candidate profile Candidate Should be CA - Chartered Accountant WFO 5+ Years Salary Upto = 20 LPA 10+ Years Salary Upto = 30 LPA WhatsApp Resume to Karan - 8700317787 & Mention FUND ACCOUNTING ( DONT CALL )
Posted 1 month ago
1 - 4 years
3 - 4 Lacs
Mumbai Suburban
Work from Office
Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmacy (B.Pharma) or Science (B.Sc), preferably in a relevant specialization. Strong understanding of FDA regulations, regulatory operations, compliance, submissions, documentation, guidelines, issues, reports.
Posted 1 month ago
5 - 10 years
5 - 8 Lacs
Vadodara
Work from Office
Preparation of DMFs for different markets in CTD and eCTD formats. Coordination with cross-functional dept to manage the documents. Supporting marketing team & QC/QA/R&D in various capacity. Preparation of Declarations and other supporting docs. Perks and benefits Transportation Canteen PF Medical Insurance
Posted 1 month ago
1 - 5 years
6 - 10 Lacs
Pune
Work from Office
About The Role : Job TitleEngineer, Associate LocationPune, India Role Description: We are looking for an Axiom developer for US regulatory reporting delivery. You'll be part of a cross-functional team thats responsible for the full software development life cycle, from conception to deployment. As an Axiom developer, one should be comfortable designs, implements, and documents end to end solutions, which include the use of Axiom v9, V10 and Oracle database, UNIX, Control-M Candidate should also be a team player with a knack for product understanding. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities AxiomSL Controller View configuration and implementation experience, including creation of data sources, data models, shorthand, portfolios, aggregations, reports, and workflows. Experience in Software Design & Development, and in supporting, troubleshooting, and resolving both user and system related issues with financial system reporting environments (e.g., AxiomSL, Oracle, data warehouses, Unix, Control-M etc.) Ability to adapt to changing business needs and requirements. Quantitative, analytical, problem solving and decision-making skills. Action oriented; drive continuous improvement in an agile environment. Organized self-starter with the ability to work independently and think creatively in a fast-paced environment. Attention to detail which includes follow up and/or escalation of issues when necessary. Strong verbal and written communication skills Ability to understand and interpret client requests/needs, and respond to questions with clear and effective answers, and give cohesive presentations. Proven team player, willing to assist others as needed to ensure that group deadlines are met, and quality standards are achieved. Participate in Agile Scrum ceremonies. Work closely with Functional Analysis and Quality Assurance teams and other developers in the team for completion of task in hand Your skills and experience IT Exp of 5-8 yrs of relevant AxiomSL development experience Proficiency in development of regulatory reports using Axiom Controller v10. Familiarity with US regulatory reports such as, IHC, CCAR, FRY9C,14Q,14A, FR2900, TIC etc. Proficiency in RDBMS (Oracle 12C, 18g or 19c) Proficiency in performance tuning of SQL queries Working knowledge of Unix shells scripting. Experience of US FED, FINMA, Treasury (TIC) Regulatory submission Understand Axiom v10 Axiom architecture and in-depth knowledge of Freeze, archival, signoff, branch dependency, favourites etc. Experience in Google Cloud platform Agile methodology delivery experience How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs
Posted 1 month ago
4 - 8 years
10 - 18 Lacs
Mumbai
Work from Office
Job Description - Preparation of local financials (under Indian GAAP & as per RBI directives). Preparation of regulatory (RBI) reports. Reports include Returns, Form - A, Special Fortnightly Returns, Form - VIII, Form - X, etc. BASEL - 3 compliance including capital adequacy computation, Pillar 3 reporting, etc. Responsibility for all reporting to RBI pertaining to Finance and reporting to the Board / Audit Committees in compliance with the Companies Act. Coordination with RBI Inspection Team, Concurrent Auditors, Statutory Auditors, etc. Preferred candidate profile Experience in the Finance Department of a bank in similar capacity. Well versed with banking products, accounting norms, and regulations. Knowledge of all RBI regulations and RBI returns relating to the Financial Control function.
Posted 1 month ago
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