Job Posting: Regulatory Affairs Manager
About the Company:
Our company is a leading pharmaceutical organization with a strong presence in India. We specialize in consumer healthcare products, pharmaceuticals, and food supplements. As a Regulatory Affairs Manager, you will be responsible for leading regulatory activities in the India/Srilanka/Nepal/Maldives market. Your role will involve developing regulatory strategies and submissions for new products, ensuring compliance with regulations, and optimizing cross-functional support within the organization.
Location: Mumbai
Job Type: Permanent
Job Requisition ID: R2718817
About the Job
Main Responsibilities:
Regulatory Compliance
- Ensure timely implementation and maintenance of product packaging and associated information in accordance with current product licenses.
- Update Marketing Authorizations in line with Company Core Safety Information.
- Ensure compliance and training to all mandatory SOPs.
- Maintain regulatory quality compliance and update regulatory databases.
- Stay updated with new regulatory requirements and assess their impact on existing and future products.
- Review and approve promotional and non-promotional materials for compliance with local regulations.
- Liaise with local manufacturing facility regarding regulatory activities.
Portfolio Management and Optimization
- Manage local maintenance activities and ensure compliance of the marketed product portfolio.
- Prepare local dossiers for products under development and territory extensions.
- Submit dossiers for local OTC switches.
- Collaborate with cross-functional teams to optimize the product portfolio.
- Conduct regulatory due diligence for business collaborations.
Drug & Food Supplements Development and Risk Management
Drug Development:
- Provide regulatory inputs to global/regional/local teams for new development.
- Coordinate local health authority approval and implementation of risk management plans.
Regulatory Database:
- Lead compliance of the regulatory registration database.
- Ensure regular tracking and closure of submissions.
Qualifications and Experience
- Degree in Pharmacy or Science or relevant Academic qualification.
- About 3-5 years of experience in Regulatory Affairs, including India and South Asia market.
- Good understanding of the consumer healthcare and pharmaceutical industry.
- Knowledge of local consumer healthcare regulations and requirements.
- Fluent in spoken and written English.
Link to Original Notification: Sanofi Careers – Regulatory Affairs Manager
