Symbiotec Pharmalab (P) Limited, a leading name in the pharmaceutical industry, invites talented professionals to become part of our team. Whether your expertise lies in regulatory affairs or biotech production, we have opportunities for you.
Position 1: Manager – Regulatory Affairs
Required Job Profile
- Qualifications:
- B.Pharma / M.Sc.
- 5-10 years of experience in API formulation
Key Responsibilities
- Prepare, review, and submit high-quality Drug Master Files (DMF) and Certificate of Suitability (CEP) applications to USFDA and other global regulatory bodies.
- Demonstrate expertise in DMF for fermentation and biotechnological-based APIs.
- Review process validation, analytical method validation, and stability protocols with a regulatory focus.
- Communicate with customers regarding DMF submissions, technical packages, and query responses.
- Ensure timely submission of annual reports, amendments (US/CEP/ASMF) for registered drug substances.
- Participate in vendor development and manage product specifications for global registration.
- Review change controls and submit post-approval changes to relevant DMFs.
- Possess knowledge of FSSAI, BRC, ISO 22000, FSSC 22000 certifications, and Halal/Kosher certification processes.
How to Apply
- Email: jai.mirchandani@symbiotec.in
Position 2: Executive / Sr. Executive – Biotech Production Downstream
Required Job Profile
- Department: Production Biotech Downstream
- Designation: Executive / Sr. Executive
- Experience: 6 to 9 years
- Qualification: M.Sc. / B.Tech
- Location: Ujjain, Madhya Pradesh (M.P.)
Job Description
- Operate in a 100KL microbial classical fermentation plant for API Pharma.
- Oversee downstream processes in biotech production.
How to Apply
- Email: Pratiksha.dubey@symbiotec.in
Why Join Symbiotec Pharmalab (P) Limited?
- Collaborate with a leading pharmaceutical company specializing in innovative API formulations and biotech production.
- Be part of a dynamic, forward-thinking team that values excellence and professional growth.
Don’t miss this opportunity! Apply today or share these roles with professionals who fit the profile.
