Senior Executive - Regulatory Affairs

Urgent Hiring for Sr. Executive - Regulatory Affairs Officer, Sion Mumbai.

Should be from Pharmaceutical/Lifesciences Industry.

Job Overview:

We are looking for an experienced and detail-oriented Senior Executive Regulatory Affairs (RA) to join our team.

Majorly EU

Key Responsibilities

• Prepare master dossiers as per EU CTD (Common Technical Document) guidance.
• Review key regulatory documents including:
• Product Development Reports (PDR)
• Module 1,2,3.
• Control Drug Processes (CDP)
• Nitrosamine risk assessments
• Elemental and residual impurity reports
• Assessment reports, stability protocols, and reports
• Process validation protocols and reports
• Drug Master Files (DMFs)
• Coordinate with clients for regulatory meetings and calls.
• Collaborate effectively with internal teams including Plant, Project Management (PM), R&D, FRD, and external stakeholders like CROs & CMOs.
• Review dossiers prepared by junior team members and provide necessary guidance.
• Handle EU variation filings for Type IA, IB, and Type II submissions.
• Maintain proper registration databases and submission records.

Required Skills & Qualifications

• B.Sc B.Pharm / M.Pharm / M.Sc in a relevant discipline.
• 5-7 years of hands-on experience in Regulatory Affairs, preferably in pharmaceutical formulations.
• Strong knowledge of EU CTD format and global regulatory guidelines.
• Proficiency in dossier compilation and review for regulated and semi-regulated markets.

For more info,

Please share your cv mentioning "Application for Sr. RA" on Whatsapp on 7738038748/7738038703

Regards,

Jhelum.