Sr. Executive-Regulatory Affairs
5 - 15 Years of Experience
Not disclosed 
Full TimeApothecon Pharmaceuticals Pvt. Ltd.
Vadodara, Gujarat, India
Posted on 18-09-2024
222 Views
1 Vacancy
Description
- Prepare, compile, and review regulatory submissions such as Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and Drug Master Files (DMF) for global markets (e.g., USFDA, EMA, CDSCO).
- Ensure timely submission of regulatory dossiers, amendments, and post-approval changes according to applicable regulations.
- Manage communication and queries from regulatory authorities and provide necessary responses.
- Develop and implement regulatory strategies to ensure timely approvals of new products, generics, and line extensions.
- Collaborate with cross-functional teams (R&D, QA, QC, Manufacturing) to provide regulatory guidance throughout the product development lifecycle.
- Ensure that the regulatory strategy aligns with company objectives and regulatory requirements of target markets.
- Lead the preparation, review, and submission of Common Technical Document (CTD) formats (Modules 1-5) for regulatory filings.
- Ensure that all dossiers, technical documents, and regulatory submissions are complete, accurate, and in compliance with regulatory guidelines.
- Coordinate with R&D, manufacturing, and QA teams to gather and verify data needed for regulatory submissions.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Preferred Education
MPharm (Master Of Pharmacy)
Key Skills
Attention to DetailProblem solvingTeam WorkCommunicatiomSr. Executive-Regulatory Affairs
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