Job Description
J.D Regulatory Affairs Associate
Collates information, communicates, and prepares responses for Health Authority queries to facilitate regulatory processes.
- Maintains and updates submission trackers to ensure accurate and up-to-date regulatory documentation.
- Supports the development of India-specific artwork, ensuring compliance with regulatory requirements.
- Supports the preparation and submission of regulatory dossiers for new drug applications, additional indication, site registrations and import licenses as and when assigned.
- Coordinates lifecycle management activities for assigned products, addressing renewals and updates as needed.
- Prepares and submits Periodic Safety Update Reports (PSURs) as and when assigned.
- Support team for testing of samples by preparing and submitting required documents and letters to NIBL or CDTL.
- To support any additional upcoming RA project as and when delegated.
Core Accountabilities
Key Result Areas/ outputs:
- Adherence to client and industry codes of conduct, ethics and good regulatory practices
- Ensure that all licensing activities for assigned products are completed in full compliance with all applicable regulations and relevant standards.
- Assist in Issue Management
- Regulatory Intelligence
- Management of India PSUR submission
- Handles submission/review/query responses for commercial products/global clinical trials including SEC preparation
- Maintain complete documentation records and all trackers maintained
- Manage changes in product Licenses and coordinate with changes, planned and in progress
- Support relevant Audits internal and external
- Support Deviations and CAPA as required
- Learn or gain detailed knowledge of critical aspects of products: commercial strategies, the content of dossiers, regulatory intelligence, regulatory timelines and supply strategy and proactive preparation of required steps, manage local testing and legal documents for new launches.
Adherence to client and industry codes of conduct, ethics and good regulatory practices
- Align with the values and vision of client
- Ensure compliance with Local legislation, Global regulatory policies, client code of conduct, Corporate
- Governance and Audit requirement
- Ensure that company confidentiality is maintained (i.e. intellectual property, product information and strategic information)
- Disclose potential breach of codes or conducts. Ensure that all licensing activities are completed in full compliance with all applicable regulations and relevant standards.
- Support in application compilation and the respective query management and communicating the progress till approval/closure within RA team.
Assist in Issue Management
- Provide detailed information of regulatory status of affected products
- Undertake assigned follow-up action where necessary
Regulatory Intelligence
- To stay updated on new regulatory guidelines, circulars, public notices, and alerts issued through Health
- Authority websites and to circulate this information within the team for timely action.
Management of India PSUR submission
- Prepare India specific PSURs based on the global PBRER
- Submit the PSURs to Health Authorities within timeline
- Responsible for responding to Health Authority Questions based on PSUR
Handling submission/review/query responses for commercial products including SEC preparation
- Manages regulatory compliance including renewal/amendments minimum supervision from manager
- Maintain complete documentation records and all trackers are timely maintained
Support relevant Audits internal and external, Deviations & CAPA action
- Support internal and external audits by ensuring all regulatory documents and processes are audit-ready and addressing audit requirements in a timely manner.
- Assist in managing deviations and implementing CAPA actions, ensuring compliance with regulatory standards and continuous process improvement.
Location : Mumbai
Essential
Education, Qualifications, Skills and Experience.
- Degree or equivalent professional qualification in related field
- Experience in quality assurance within a pharmaceutical manufacturing environment.
Desirable: Post-graduate qualification B.Pharm / M.Pharm
