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).
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Gracure Pharmaceuticals Hiring for Drug Regulatory Affairs[/caption]
How to Apply
To apply, send your updated resume to the following email addresses:
https://pharmastuff.org.in/job/gracure-pharmaceuticals-hiring-drug-regulatory-affairs-team
