Position: Regulatory Affairs Manager

Location: [Specify Location, if applicable]

Job Profile:

Qualifications:

• B.Pharm or M.Sc.
• 5-10 years of experience in API formulation.

Key Responsibilities:

1. Preparation and Submission:
   • Prepare, review, and submit high-quality Drug Master Files (DMFs) and Certificate of Suitability (CEP) applications for Active Pharmaceutical Ingredients (APIs) to various regulatory authorities (e.g., USFDA, EU, Rest of the World).
2. Expertise in Specialized DMFs:
   • Prepare and review DMFs for APIs derived from fermentation and biotechnological processes.
3. Validation Reviews:
   • Review process validation, analytical method validation, and stability protocols/reports with a focus on regulatory compliance.
4. Customer Communication:
   • Provide open part DMF, technical packages, and respond to customer queries to ensure global product registration.
5. Timely Submissions:
   • Ensure the submission of Annual Reports, Amendments in the US, and CEP variations/ASMF amendments in the EU for registered drug substances.
6. Vendor Development:
   • Participate in vendor development projects, focusing on product specifications and registration requirements.
7. Change Control:
   • Review and submit post-approval changes to relevant DMFs and authorities.
8. Knowledge of Certifications:
   • Familiarity with FSSAI licensing, BRC, ISO 22000, and FSSC 22000 certification, including document preparation and application management for Halal and Kosher certifications.

How to Apply: Send your CV to:

• Jai.mirchandani@symbiotec.in
• Pratiksha.dubey@symbiotec.in