Hiring Regulatory Affairs Manager at Sanofi- Apply before 30th November, 2023

Heading: Regulatory Affairs Manager Job Post

Subheading: Job Description

Role Overview:
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.

Key Responsibilities:

• 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.

Main Responsibilities:

Regulatory Compliance:

• 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.

Drug Development:

• Provide regulatory inputs to global/regional/local teams for new development considering local requirements (CMC, labeling, clinical trials).

Risk Management:

• Coordinate health authority approval and implementation of risk management plans and educational materials.
• Ensure public availability of approved product information for risk minimization.

Regulatory Database:

• Lead regulatory registration database compliance.
• Track and close submissions in local trackers and global databases regularly.

Candidate Profile:

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.

Technical Skills:

• 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.

Additional Information:

• 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
• For more articles, Kindly Click here.For pharmaceutical jobs, follow us on LinkedIn

  For more jobs, kindly visit our job section.

  www.pharmaceuticalcarrier.com/Jobs