Company:
Deccan Nutraceuticals Pvt Ltd (DNPL), established in 2001, specializes in manufacturing bulk drugs/APIs. Located 30 km from Pune station, DNPL has been successfully audited by USFDA five times and by EDQM twice.
Position Name:
Regulatory Affairs Manager (Pharmaceuticals/Bulk Drugs)
Organization:
Deccan Nutraceuticals
Qualification:
MS/M.Sc(Science) in Chemistry, M.Pharma
Experience:
5 – 10 years
Salary:
₹8-12 Lacs P.A.
Location:
Pune, Maharashtra, India
Vacancy Details:
Department | Regulatory Affairs |
---|---|
Position | Manager |
Qualification | MS/ M.Sc in Chemistry or M.Pharma |
Experience | 5 – 10 years |
Salary | ₹8-12 Lacs P.A. |
Location | Pune, Maharashtra, India |
Job Description:
- DMF Preparation and Submission: Independently prepare, compile, and submit DMFs as per USFDA and EDQM requirements.
- Regulatory Compliance: Ensure compliance with all applicable regulations and guidelines.
- Cross-Department Coordination: Collaborate with R&D, QA, QC, and Production to gather data for DMF preparation.
- Documentation and Record Keeping: Maintain organized and compliant regulatory files.
- Regulatory Strategy: Develop and implement strategies for DMF approval and maintenance.
- Communication and Liaison: Effectively communicate regulatory matters.
- Knowledge Maintenance: Stay updated on regulatory requirements and guidelines.
- Project Management: Manage multiple projects and ensure timely submissions.
Skills:
Excellent communication and organizational skills.
Important Details:
- Selection Process: Interview
- Mode of Interview: Face-to-Face
- Rounds of Interview: HR
Contact Information:
- Contact Person: Ms. Pooja
- Phone: 7770015985
- Email: hr@dnplfactory.com
- Address: Gat No.1065, Golegaon Road, Village – Markal, Off Alandi-Markal Road, Tal-Khed, Pune, Maharashtra, India.
How to Apply:
Interested candidates can visit our website for more details and to apply: Deccan Nutraceuticals Website