Position: Assistant Manager – Regulatory Affairs (Europe)
Location: Corporate Office, Greater Noida
Job Responsibilities:
- Europe/Australia/Canada:
- Author, review, and submit drug product dossiers for EU, UK, Australia, and Canada.
- Manage product life cycle activities and assess post-approval changes.
- Publish eCTD documents.
- Possess thorough knowledge of CMC and Module 1 requirements.
- Preparation & Submission:
- Author, review, and submit new dossier applications, variations, renewals, and RFIs for EU (DCP/MRP/NP), UK, Australia, and Canada Health Authorities.
- Author Module 1 and quality modules.
- Assess post-approval changes and maintain life-cycle regulatory activities.
- Coordinate with cross-functional teams to plan and complete regulatory filings.
- Review and finalize artwork/labels per current QRD guidelines.
- Stay updated on technical guidelines, regulatory requirements, and trends.
- Publish eCTD documents.
- Coordination:
- Interface with R&D and other business functions to ensure timely project-specific regulatory strategies.
- Coordinate with API vendors to resolve regulatory technical queries.
- Review technical documents such as process validation, AMV, stability, and composition against DMF/dossier requirements.
- Reporting & Maintenance:
- Maintain regulatory files and databases.
Qualifications:
- Education: Master’s or Bachelor’s degree in Pharmacy
- Certifications (Preferred): PGDRA
- Experience: 3-10 years in Dosage Regulatory Affairs for regulated markets, with at least 5 years post-qualification.
If you are a proactive professional with a strong background in regulatory affairs, especially within the EU, UK, Australia, and Canada markets, we invite you to apply for this dynamic role.
