Deputy Manager-Regulatory Affairs
0 - 5 Years of Experience
Not disclosed 
Full TimeAbryl Laboratories
Dera Bassi, Punjab, India
Posted on 24-12-2024
49 Views
1 Vacancy
Description
- Oversee regulatory compliance for product development, manufacturing, and marketing across domestic and international markets.
- Lead the preparation, review, and submission of regulatory documents to authorities like FDA, EMA, CDSCO, and other relevant bodies to ensure market authorization of new products.
- Develop and implement regulatory strategies in alignment with business goals, ensuring timely product approvals.
- Lead and manage the regulatory submission process for new product registrations, including dossiers, labeling, and clinical trial applications (CTA).
- Coordinate regulatory filings for drugs, medical devices, biologics, or cosmetics as per applicable regulatory requirements.
- Ensure timely submission and approval of regulatory documents for the commercialization of products across various geographies.
- Manage post-market surveillance reporting and regulatory updates for products in the market.
- Review and approve regulatory documents, including registration dossiers, clinical trial documents, and technical files for accuracy and regulatory compliance.
- Maintain up-to-date regulatory filing systems and documentation, ensuring all documents are accessible for audits and inspections.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Key Skills
Attention to DetailProblem solvingCommunicationTeam Work
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