About Sanofi
Sanofi is dedicated to building a healthier, more resilient world by discovering, developing, and delivering medicines and vaccines to millions of people worldwide.
Position: Regulatory Affairs Manager
Job Description
The Regulatory Affairs Manager plays a pivotal role in leading regulatory activities in the India/Srilanka/Nepal/Maldives market. This role involves providing regulatory strategies, managing regulatory submissions for new products across various categories (Rx/OTC/Food supplements), ensuring compliance, and optimizing the portfolio for value creation.
Responsibilities
- Regulatory Compliance:
- Ensure compliance of product packaging and associated information with current product licenses.
- Update Marketing Authorizations in line with Corporate requirements.
- Ensure adherence to SOPs, quality, and compliance with local regulatory activities.
- Stay updated with new regulatory requirements and assess their impact on existing products.
- Review and approve promotional and non-promotional materials for compliance with local regulations.
- Portfolio Management and Optimization:
- Support local maintenance activities and ensure compliance with the marketed product portfolio.
- Prepare local dossiers for products under development and territory extensions.
- Provide regulatory input for product portfolio optimization strategies.
- Drug & Food Supplements Development and Risk Management:
- Provide regulatory inputs for new drug development and risk management plans.
- Coordinate local health authority approval and implementation of risk management plans.
- Lead the compliance of the regulatory registration database.
Candidate Profile
- A degree in Pharmacy or Science is desirable.
- Experience: 3-5 years in Regulatory Affairs, including managing the India and South Asia markets.
- Good understanding of the consumer healthcare and pharmaceutical industry.
- Knowledge of local regulations and Health Authorities’ requirements.
- Strong communication and leadership skills.
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