Regulatory Affairs Executive
3 - 5 Years of ExperienceNot disclosed Full Time
Valence Labs
Rajpura, Punjab, India
Posted on 20-08-2024
209 Views
1 Vacancy
Description
- Ensure that all products comply with current regulations and standards, including those related to safety, efficacy, and labeling.
- Compile and maintain regulatory dossiers, including product information, clinical data, and technical specifications.
- Maintain accurate and up-to-date records of all regulatory submissions, approvals, and correspondence with regulatory authorities.
- Manage the renewal and variation of product licenses, ensuring continuous compliance with regulatory requirements.
- Assist in obtaining regulatory approvals for entering new markets, coordinating with local regulatory agencies and consultants.
- Develop and execute regulatory strategies for product development, approval, and post-market surveillance.
- Identify potential regulatory risks and develop mitigation strategies to ensure successful product approvals and market entry.
- Develop and deliver training programs for internal teams on regulatory requirements, processes, and best practices.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Preferred Education
MSc Chemistry
Key Skills
Regulatory ComplianceDocument ManagementMarket ExpansionRegulatory StrategyTraining and Awareness
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