Regulatory Affairs Manager
Job Description
The Regulatory Affairs Manager assumes a pivotal scientific leadership role, spearheading regulatory activities within the India/Sri Lanka/Nepal/Maldives markets. This position devises regulatory strategies and oversees submissions for new products across Rx/OTC/Food supplement categories, supporting both existing and emerging portfolios. Additionally, the Regulatory Manager ensures regulatory compliance, oversees data management, and champions a portfolio approach for scientific value creation, all while adhering to established timelines.
Key Responsibilities at Sanofi
- Regulatory Strategies: Formulate regulatory strategies to accelerate product innovation and brand growth within the designated markets.
- Compliance Oversight: Ensure compliance of the existing Consumer Healthcare (CHC) portfolio and facilitate timely approvals for all marketing authorizations.
- Submission Quality: Deliver high-quality regulatory submissions within agreed-upon timelines, collaborating closely with internal and external stakeholders.
- Cross-functional Collaboration: Foster effective communication and collaboration with Medical, Marketing, and business teams to achieve strategic objectives.
- Continuous Learning: Maintain and enhance regulatory skills through ongoing training and knowledge sharing with colleagues.
Main Responsibilities at Sanofi
- Regulatory Compliance: Ensure adherence to product packaging standards, update Marketing Authorizations as per corporate requirements, and uphold regulatory SOPs.
- Portfolio Management: Manage local maintenance activities, prepare dossiers for new product developments, and facilitate OTC switches.
- Risk Management: Coordinate local health authority approvals for risk management plans and ensure the availability of approved product information.
- Regulatory Database: Lead compliance efforts for regulatory registration databases and track submissions in local and global databases.
Candidate Profile Required at Sanofi
- Qualifications: Degree in Pharmacy or relevant scientific field.
- Experience: 3-5 years in Regulatory Affairs, with a focus on the India and South Asia markets.
- Industry Knowledge: Familiarity with consumer healthcare and pharmaceutical industries, including regulatory frameworks and R&D processes.
- Regulatory Expertise: Proficiency in local regulatory requirements and the ability to assess their impact on product development and submission strategies.
Additional Information
- Experience: 3-5 years
- Qualification: Degree in Pharmacy or Science
- Location: Mumbai, India
- Industry Type: Pharma/Healthcare/Clinical Research
- Functional Area: Regulatory Affairs
- End Date: 30th May 2024
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