Jubilant Generics Hiring Assistant Manager – Regulatory Affairs
Assistant Manager – Regulatory Affairs (Europe) | Jubilant Generics Limited
- Location: Corporate Office, Greater Noida
- Qualification: Master/Bachelor’s degree in Pharmacy
- Experience: 3-10 years
- Salary: ₹2.00 – ₹5.4 lac (Approx)
About Jubilant Generics:
With a presence in over 50 countries, including the US, Europe, Canada, Japan, and Australia, Jubilant Generics is a vertically integrated pharmaceutical company engaged in R&D, manufacturing, sales, and distribution of prescription and OTC pharmaceutical products.
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.
- 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.
Role Details:
| Detail | Description |
|---|---|
| Education | Master’s or Bachelor’s degree in Pharmacy |
| Certifications | PGDRA (Preferred) |
| Experience | 3-10 years in Dosage Regulatory Affairs for regulated markets, with at least 5 years post-qualification. |
| Location | Corporate Office, Greater Noida |
| Salary | ₹2.00 – ₹5.4 lac (Approx) |
| Key Responsibilities | Author, review, and submit drug product dossiers, manage product life cycle, publish eCTD documents, coordinate regulatory filings, maintain regulatory files. |
| Markets | EU, UK, Australia, Canada |
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.