PRG Pharma

Title: Assistant Manager Regulatory AffairsLocation: Netaji Subhash Place, Pitampura, DelhiExperience Required: 3- 4 YearsDepartment: Regulatory AffairsEmployment Type: Full-TimeAbout the Role:The Assistant Manager Regulatory Affairs will be responsible for managing regulatory submissions, ensuring compliance with national and international regulatory standards, handling regulatory queries, and supporting product lifecycle management.The ideal candidate should have strong experience with dossier preparation, regulatory documentation, and exposure to ROW, semi-regulated, and regulated markets.Key Responsibilities:1. Regulatory Documentation & Dossier Preparation:- Prepare, review, and compile regulatory dossiers in CTD/eCTD/ACTD formats for ROW, semi-regulated, and regulated markets.- Ensure timely submission of dossiers for product approvals, renewals, variations, and updates.- Maintain high-quality documentation aligned with regulatory requirements and internal standards.Regulatory Submissions:- Prepare, review, and submit regulatory filings for obtaining and maintaining approvals for medical devices or pharmaceutical products in domestic and international markets.- Coordinate with external agencies and regulatory authorities for smooth submission and follow-ups.Regulatory Compliance:- Ensure adherence to national and global regulatory requirements across all product lines.- Review and approve artwork, product labeling, IFU (Instructions for Use), and packaging to ensure compliance with market-specific guidelines.- Maintain up-to-date regulatory files, documentation, and related records.Regulatory Queries & Communication:- Handle regulatory queries from authorities, partners, and internal stakeholders.- Provide accurate, well-supported responses in a timely manner to facilitate approvals.Regulatory Strategy:- Develop and implement regulatory strategies in collaboration with R&D, QA, Manufacturing, and other cross-functional teams.- Ensure regulatory considerations are integrated throughout the product lifecyclefrom development to Affairs Support:- Collaborate with Clinical Affairs team in planning and executing clinical trials required for regulatory submissions.- Assist in preparation of clinical documentation and evidence reports.Post-Market Surveillance:- Monitor adverse events, customer complaints, and field actions in accordance with regulatory guidelines.- Implement CAPA (Corrective and Preventive Action) measures as required.Regulatory Intelligence:- Stay updated with evolving global regulations, guidelines, and industry trends.- Communicate key regulatory changes to relevant departments to ensure business readiness.Audit Preparation & Inspection Readiness:- Prepare documentation and teams for regulatory audits and inspections.- Conduct mock audits and internal assessments to ensure constant readiness.10. Cross-Functional Collaboration:- Work closely with Quality Assurance, R&D, Manufacturing, Marketing, and Supply Chain teams to ensure seamless regulatory alignment.- Support internal teams with regulatory insights for product development, labeling, and compliance & Skills:Required Qualifications:- Bachelors or Masters degree in Pharmacy, Life Sciences, Biotechnology, or related field.- 3- 4 years of experience in Regulatory Affairs (pharma/medical devices).- Strong understanding of regulatory pathways for ROW and semi-regulated markets.- Hands-on experience with CTD/eCTD/ACTD dossier compilation.Technical Skills:- Knowledge of regulatory frameworks (WHO, USFDA, EMA, CDSCO, etc.- Strong understanding of regulatory submission processes and documentation management.- Experience reviewing labeling, artwork, and product-related documents.- Familiarity with post-market surveillance and CAPA processes.Soft Skills:- Strong analytical and problem-solving abilities.- Effective written and verbal communication skills.- Excellent attention to detail and documentation accuracy.- Ability to work collaboratively with cross-functional teams.- Strong organizational and time-management skills (ref:iimjobs.com)