- Full Time
Sanofi is a global healthcare company with a clear mission: to harness the power of scientific innovation to enhance people’s lives. One significant development is the partnership with the World Health Organization (WHO) signed on December 10, 2020, with the goal of eliminating sleeping sickness by 2030. This collaboration underscores Sanofi’s commitment to using the advancements of science to tackle critical global health issues.
Sanofi is actively engaged in various initiatives to make a positive impact on public health. For instance, the company is dedicated to providing vaccines to support the global effort to eradicate polio, developing medicines to combat sleeping sickness, and establishing expert networks to address pediatric cancers. A key focus is addressing gaps in the care of childhood cancer patients. In research and development (R&D), Sanofi is working on the development of potential therapies to reduce childhood cancer-related deaths and accelerate the clinical trial process, often in partnership with leading scientific institutions.
Furthermore, Sanofi’s philanthropic arm, Foundation S, is actively involved in enhancing the survival rates of children with cancer in low- and middle-income countries (LMICs) through its established “My Child Matters” program. This program reflects Sanofi’s commitment to improving the lives of children suffering from cancer in underserved regions.
Heading: Regulatory Affairs Manager Job Post
Subheading: Job Description
The Regulatory Manager holds a key leadership position with a focus on regulatory activities in the India/Srilanka/Nepal/Maldives market. This role is pivotal in shaping regulatory strategies, submissions for new products across Rx/OTC/Food supplements, and ensuring compliance and data management. The incumbent plays a crucial role in fostering a portfolio approach to create scientific value, meeting clear priorities, and ensuring timely project delivery.
- Regulatory Strategies: Provide regulatory strategies for brand and innovation, expediting the introduction of new products, packaging, and claims to the market.
- Compliance Management: Ensure compliance of the existing Consumer Healthcare (CHC) portfolio, secure timely marketing authorizations, and provide input for new product development.
- Submission Quality: Maintain high-quality submissions within agreed timelines with country head and relevant health authorities.
- Cross-functional Collaboration: Optimize cross-functional support within the organization by fostering effective communication with Medical, Marketing, and business teams to meet priorities.
- Continuous Learning: Stay updated with the regulatory environment through appropriate training and knowledge sharing with team members.
- Update and maintain product packaging and associated information according to current licenses.
- Ensure Marketing Authorizations are updated per Corporate Core Safety Information requirements.
- Oversee compliance with mandatory Standard Operating Procedures (SOPs).
- Uphold quality and compliance in local regulatory activities in line with corporate and national policies.
- Monitor new regulatory requirements and assess their impact on existing and in-development products.
- Review and approve promotional and non-promotional materials in compliance with local regulations and internal guidelines.
- Liaise with local manufacturing facilities affecting Regulatory Authorities’ dossiers.
Portfolio Management and Optimization:
- Manage local maintenance activities and portfolio compliance.
- Prepare local dossiers for products under development and territory extensions.
- Submit dossiers for local OTC switches.
- Ensure timely dossier approvals and risk mitigation in partnership with CSH.
- Provide regulatory input for portfolio optimization and product pruning.
- Conduct regulatory due diligence for business collaborations.
- Provide regulatory inputs to global/regional/local teams for new development considering local requirements (CMC, labeling, clinical trials).
- Coordinate health authority approval and implementation of risk management plans and educational materials.
- Ensure public availability of approved product information for risk minimization.
- Lead regulatory registration database compliance.
- Track and close submissions in local trackers and global databases regularly.
Qualifications Required at Sanofi:
- Degree in Pharmacy or Science
- 3-5 years of experience in Regulatory Affairs, with a focus on the India and South Asia market.
- Strong understanding of the consumer healthcare and pharmaceutical industry, drug development, and R&D processes.
- Knowledge of the local Consumer Health regulatory environment, including CDSCO, FSSAI, and State FDA-related activities.
- Proficiency in consumer healthcare regulations and Health Authorities’ requirements, with the ability to evaluate their impact within the drug development environment.
- Experience Required at Sanofi: 3-5 years
- Qualification: Degree in Pharmacy or Science Degree
- Location: Mumbai
- Industry Type: Pharma/Healthcare/Clinical Research
- Application Deadline: November 30, 2023
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