LATEST PHARMA JOB – Regulatory Manager Role at SANOFI – APPLY HERE

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Regulatory Manager - CHC role

LATEST PHARMA JOB – Regulatory Manager – CHC role at SANOFI – APPLY BELOW

Role : Regulatory Manager – CHC

Locations : Mumbai

Time type : Full time

Job requisition id : R270888

Education :

  • Degree in Pharmacy or Science Degree or relevant Academic qualification is desirable.
    Language skills
  • Fluent spoken and written English

JOB PURPOSE

  • 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 required for Regulatory Manager – CHC role at sanofi :

  • 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

Cultural traits / P2W Behavior :

  • Push to go beyond the level we have operated until now : constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment
  • Put the interest of the organization ahead of own of those of his her team : consider both short and long term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level. Collaborates transversally.
  • Act in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings an external perspective into decisions
  • Take action and don’t wait to be told what to do: take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward

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Check out Rasayanika for more updates

Here are few potential interview questions and sample answers for the Regulatory Manager – CHC role at sanofi :

1. Can you provide an overview of your regulatory affairs experience and your familiarity with the India/South Asia market?

Sample Answer: I have approximately 4 years of experience in Regulatory Affairs, specifically in managing the India and South Asia markets. Throughout my career, I’ve gained a deep understanding of the regulatory landscape in these regions, including the requirements of CDSCO, FSSAI, and State FDA. This knowledge has allowed me to effectively navigate the complexities of consumer healthcare regulations and achieve timely approvals for marketing authorizations.

2. Could you describe your approach to ensuring regulatory compliance for consumer healthcare products?

Sample Answer: Ensuring regulatory compliance is of paramount importance in the consumer healthcare sector. I follow a meticulous approach by regularly updating product packaging and associated information according to the latest product licenses. I also ensure that Marketing Authorizations are consistently aligned with the Company’s Core Safety Information. Furthermore, I review and approve promotional and non-promotional materials to guarantee compliance with local regulations, codes of conduct, and internal guidelines.

3. How do you stay updated with the ever-evolving regulatory requirements and incorporate them into your strategies?

Sample Answer: Staying up-to-date with evolving regulatory requirements is crucial in this role. I actively follow the development of new regulations and assess their potential impact on both existing and future products. I engage in continuous professional development, attend relevant training sessions, and participate in industry conferences. This proactive approach helps me ensure that our products remain compliant and aligned with the latest guidelines.

4. Can you share an example of a challenging situation you’ve encountered while managing regulatory activities? How did you address it?

Sample Answer: One challenging situation I faced was coordinating the implementation of a complex risk management plan across multiple products. To address this, I collaborated closely with cross-functional teams, including health authorities and internal stakeholders. We devised a comprehensive plan, ensured timely approvals, and disseminated approved product information to minimize risks effectively.

5. How do you manage the balance between meeting regulatory requirements and supporting business objectives?

Sample Answer: Balancing regulatory requirements with business objectives requires a strategic approach. I collaborate closely with Medical, Marketing, and business teams to align priorities and develop clear strategies. By fostering effective communication and cross-functional support, I ensure that both regulatory compliance and business goals are met harmoniously.

ALL THE BEST !

 

 

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