Gracure Pharmaceutical Ltd. is a Delhi based pharmaceutical company, established in 1992 by Mr. A.S Bhargava with the vision of making world-class affordable medicines. Gracure is a research-driven forward-looking pharmaceutical company with expertise in the development of various finished dosages.
Since its inception in 1992, Gracure pharmaceuticals Ltd. has been focused to manufacture an extensive spectrum of pharmaceutical formulation products.
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We engage in the research, development, manufacturing, sourcing, marketing, and distribution of high-quality pharmaceutical products. We are a fully integrated company with in-house business development, R&D, manufacturing, and regulatory compliance capabilities.
Position: Executive Regulatory Affairs – Regulated Markets Canada, Australia, UK
Location: Delhi
Job Description:
Roles and Responsibilities:
- Collaboration with internal stakeholders (manufacturing, R&D, stability) to compile quality dossiers timely, as per country-specific requirements.
- Review of CMC documents for submission viz. API DMF, BMR, Specifications/STP, Method validation reports, stability, process validation data, etc.
- Follow up with stakeholders to get corrected documents in line with review comments.
- Dossier writing with a focus on the accuracy and adequacy of data.
- Preparation and review of responses to queries timely.
- Preparation and review of Variations and renewals as per country-specific requirements.
Desired Candidate Profile:
- M. Pharm(QA/ Pharmaceutics/pharm Chem) or B.Pharm with good percentile.
- Maintain good communication and collaboration with the team and seniors.
- Good written/ spoken English.
Qualification: B.Pharma/M.Pharma
Experience: 2-5 Years
Salary: Negotiable
Contact Details:
Mr. Rajat Gupta
hr@gracure.com, rajat.gupta@gracure.com
OR
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