Emcure Pharmaceuticals, a leading name in the pharmaceutical industry, is currently hiring for the position of Officer – Regulatory Affairs API in Pune. This is an excellent opportunity for professionals with 3 to 5 years of experience in Regulatory Affairs, specifically in the API (Active Pharmaceutical Ingredient) domain. If you have a post-graduation in Chemistry and a strong background in handling regulatory submissions, this role could be your next career milestone.
Job Overview
- Position: Officer – Regulatory Affairs API
- Location: Pune, Maharashtra
- Experience: 3 to 5 years
- Qualification: Post-Graduation in Chemistry
- Key Skills: Regulatory Affairs, DMF Filing, USFDA, ASMF, CEP, Educe Software
Job Description
As an Officer – Regulatory Affairs API at Emcure, you will be responsible for managing regulatory submissions and ensuring compliance with global regulatory standards. Your primary focus will be on API-related regulatory activities, including DMF (Drug Master File) filings, amendments, and annual reports.
Key Responsibilities
- Regulatory Submissions:
- Prepare and file original DMFs, amendments, and annual reports for regulatory agencies such as USFDA, Brazil, Europe, and Japan.
- Handle ASMFs (Active Substance Master Files) and CEPs (Certificates of Suitability to the European Pharmacopoeia) for the European market.
- Coordination and Compliance:
- Collaborate with cross-functional teams to gather necessary data for DMF filings and quality updates.
- Ensure timely and accurate submissions to meet regulatory deadlines.
- Software Proficiency:
- Utilize the Educe Software system for regulatory submissions to the US and Europe.
- Customer Support:
- Compile and provide open part DMFs to customers as required.
Eligibility Criteria
- Educational Qualification: Post-Graduation in Chemistry or a related field.
- Work Experience: 3 to 5 years of experience in Regulatory Affairs, specifically in the API sector.
- Technical Skills: Proficiency in handling regulatory submissions, DMF filings, and familiarity with Educe Software.
Why Join Emcure?
Emcure Pharmaceuticals is a globally recognized organization known for its innovation and commitment to quality. By joining Emcure, you will be part of a dynamic team that values expertise and fosters professional growth. This role offers a unique opportunity to work on global regulatory projects and enhance your career in the pharmaceutical industry.
