Analyst Regulatory Affairs
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Job Location:
Monthly Salary:
Posted on:
13-10-2025
Vacancies:
1 Vacancy
Job Summary
Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses regulatory strategy note controlled correspondences Briefing books labeling artworks and ScA meeting packages. Coordinate with internal stake holders (R&D AR&D SCM FTO CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records specifications analytical method Stability protocols PVPs etc).In coordination with eCTD / labeling team ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines.
Qualifications :
M. Pharm OR PhD
Additional Information :
Good communication skill (Written and Oral) Self-starter with a go-getter attitude and team player Quick learner and able to prioritize information Good interpersonal skills High level of proficiency in networking internally and externally.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Dr. Reddys Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Cant Wa ... View more
