Symbiotec Hiring for Regulatory Affairs – Sr Manager, AGM Positions

Symbiotec Pharmalab (P) Limited, a leader in the manufacturing of Active Pharmaceutical Ingredients (APIs), is hiring for the positions of Regulatory Affairs Sr. Manager and Assistant General Manager (AGM). This opportunity is ideal for seasoned professionals with a B. Pharma or MSc. degree and 10–22+ years of experience in API formulation. Join a company that values expertise, innovation, and compliance excellence.

Key Responsibilities

As a Sr. Manager/AGM in Regulatory Affairs, you will:

1. Prepare and Review Drug Master Files (DMFs): Ensure high-quality submissions to regulatory authorities such as USFDA, EDQM, and others worldwide.
2. Handle Biotechnological APIs: Review and prepare DMFs for fermentation and biotechnological-based APIs.
3. Regulatory Documentation: Review process validation, analytical method validation, and stability protocols with a focus on compliance.
4. Global Product Registration: Provide DMF open parts, technical packages, and respond to customer queries to facilitate worldwide registration.
5. Compliance Management: Manage timely submission of annual reports, amendments, and variations for US and EU markets.
6. Vendor Development: Assist in product specification alignment and registration commitments.
7. Post-Approval Changes: Oversee change control processes and submissions for DMF updates globally.
8. Certification Expertise: Manage FSSAI License, BRC, ISO 22000, and FSSC 22000 certifications, as well as applications for Halal and Kosher certifications.

Qualification and Experience

• Educational Background: B. Pharma or MSc.
• Experience: 10–22+ years in API formulation with a strong understanding of regulatory affairs.
• Skills: Expertise in DMF preparation, regulatory compliance, and technical documentation.

How to Apply

Interested candidates are encouraged to send their CVs to Jai.mirchandani@symbiotec.in.