Location
Mumbai | India
Job description
The Regulatory Manager is a management role that manages the regulatory activities involved in the India/Srilanka/Nepal/Maldives market. Manage the regulatory compliance and data needs including regulatory quality compliance, regulatory database updates and maintenance, etc. Support the portfolio approach for Science value creation ensuring clear priorities are defined and delivered within the areas of responsibilities. Ensure the vision for the country activities are delivered within timelines agreed.
The Regulatory Manager will:
- Ensuring compliance of the existing CHC portfolio, effective and timely approval of all marketing authorizations, maintenance, provide appropriate input on the development of new products.
- Ensure high quality submissions within timelines agreed with country head, business and/or health authorities
- Optimize on cross-functional support within the organization, ensuring effective communication with the Medical, Marketing and business teams to deliver on all priorities.
- Ensure they maintain and develop their regulatory skills and keep up-to date with the regulatory environment by appropriate trainings. Learn from other team members.
Main responsibilities:
Regulatory Compliance
- Ensure product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses.
- Ensure that Marketing Authorizations are updated in line with Company Core Safety Information according to Corporate requirements
- Ensure compliance and training to all mandatory SOPs is completed
- Ensure quality and compliance of local regulatory activities in line with corporate policies, national regulations. Ensure maintenance of regulatory databases.
- Actively follow the development and emergence of new regulatory requirements and assess their impact on the existing products and in development.
- Review and approve promotional and non-promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Coordinate review with the responsible functions in the country. Ensures consistency and conformity to the various published guidelines - Sanofi, Legislation and Industry code, as applicable.
- Liaison with local manufacturing facility in connection with all aspects that affect the dossier held by the relevant Regulatory Authorities.
Portfolio Management and Optimization
- Support the management of the local maintenance activities and ensure compliance of the marketed product portfolio in the countries in scope.
- Manage the preparation of local dossiers for the products under development and territory extensions
- Prepare and submit dossiers for local OTC switches
- Ensure that best efforts are provided to get timely approvals of dossiers and all risk mitigation plans are in place to avoid any undue risk to business, in partnership with CSH.
- Provide RA input to product portfolio optimization and product pruning at affiliate level and give RA input to global product portfolio optimization strategies and constantly and proactively engage with HAs
- Conduct regulatory due diligence for business collaborations
Drug Development and Risk Management
- Drug Development:
- Give Input to Global teams for drug development with regards to local needs (labelling, clinical trials).
- Risk Management:
- Co-ordinate the local health authority approval and implementation of risk management plans and educational material.
- Ensure public availability of current approved product information for risk minimization (SmPC, educational material, PIL, compendia)
Regulatory Database
- Lead the compliance of the regulatory registration database.
- Ensure regular tracking and closure of submissions in local trackers and global databases.
About you
Experience:
- About 3-5 experience in Regulatory Affairs including managing India and South Asia market.
- Good understanding of the consumer healthcare and pharmaceutical industry, drug development environment, and R&D processes and objectives
- Knowledge of the local Consumer Health environment (regulatory, regional Industry Associations, Public & Government affairs) including CDSCO, FSSAI, State FDA related activities
- Good knowledge of consumer healthcare regulations and requirements, Health Authorities regulations and ability to evaluate impact of those regulations within the drug development environment and to lead discussions of the requirements and its impacts within submission teams
Education
- Degree in Pharmacy or Science Degree or relevant Academic qualification is desirable.
Language skills
- Fluent spoken and written English
Job tags
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