Drug Regulatory Affairs Manager/Sr. Manager and Executive/Sr. Executive Hiring at Gracure Pharmaceuticals
- About Gracure Pharmaceuticals
- Job Overview: Drug Regulatory Affairs Positions
- Job Responsibilities
- Qualifications and Experience
- How to Apply
Gracure Pharmaceuticals Limited, is currently hiring for Drug Regulatory Affairs (DRA) roles. With a strong focus on the regulated markets of Canada, Australia, and Europe, Gracure is offering excellent opportunities for professionals in this vital department. If you’re experienced in regulatory submissions, dossier preparation, and compliance for international markets, this is the perfect career advancement opportunity.
About Gracure Pharmaceuticals
Founded in 1992 by Mr. A.S Bhargava, Gracure Pharmaceuticals Limited has grown into a research-driven pharmaceutical company with a global reach. Headquartered in Delhi, Gracure is committed to producing world-class affordable medicines. The company’s state-of-the-art R&D center and EU-GMP approved manufacturing facility are located in Bhiwadi, Rajasthan, making Gracure a leading player in developing and manufacturing finished dosage forms for various therapeutic areas.
Job Overview: Drug Regulatory Affairs Positions
Gracure Pharmaceuticals is actively hiring for Manager/Sr. Manager and Executive/Sr. Executive roles in the Drug Regulatory Affairs (DRA) department. These roles focus on ensuring the company’s pharmaceutical products meet all regulatory requirements for key global markets like Canada, Australia, and Europe.
Key Positions Available:
- Manager/Sr. Manager – Drug Regulatory Affairs
- Experience: 10 to 16 years in DRA, with significant exposure to regulated markets.
- Executive/Sr. Executive – Drug Regulatory Affairs
- Experience: 3 to 7 years in DRA, with experience in dossier preparation for regulated markets.
- Qualification: B Pharmacy or M Pharmacy.
- Location: New Delhi (Moti Nagar)
Job Responsibilities
As part of the Drug Regulatory Affairs team at Gracure Pharmaceuticals, the selected candidates will:
- Prepare, compile, and submit regulatory dossiers for new product registrations and variations for international markets.
- Ensure that all submissions comply with current regulations and guidelines for the target markets of Canada, Australia, and Europe.
- Maintain close communication with regulatory bodies and agencies to facilitate the approval process and respond to queries.
- Collaborate with internal departments, including R&D and manufacturing, to gather all necessary documentation for regulatory submissions.
- Ensure that post-marketing regulatory commitments are met, including renewals and amendments.
- Monitor regulatory changes in key markets and ensure timely updates to internal teams.
Qualifications and Experience
To be considered for these roles in Drug Regulatory Affairs, applicants must meet the following qualifications:
- Manager/Sr. Manager:
- Experience: 10 to 16 years in DRA, specifically for regulated markets (Canada, Australia, Europe).
- Proven track record of managing regulatory submissions and liaising with international authorities.
- Location: New Delhi (Moti Nagar).
- Executive/Sr. Executive:
- Education: B Pharmacy or M Pharmacy.
- Experience: 3 to 7 years in DRA, with practical experience in dossier preparation, product registrations, and handling international regulatory audits.
- Location: New Delhi (Moti Nagar).
How to Apply
To apply, send your updated resume to the following email addresses:
