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    Lead - Regulatory Affairs

    Sanofi
    5+ years
    Not Disclosed
    Delhi
    15 May 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Lead - Regulatory Affairs

    Company: Sanofi

    Experience: 5+ years

    Location: New Delhi

    Job Description:

    Sanofi is seeking a Lead for Regulatory Affairs to manage the entire spectrum of regulatory activities for the affiliate, including Vaccines, Biologicals, Pharma, bulk drugs, and manufacturing sites with CDSCO. The Lead will be responsible for securing time-bound approvals and completing submissions within deadlines. They will act as the primary point of contact between the organization and health authorities, ensuring effective communication channels and facilitating clear dissemination of information. Collaboration with internal departments such as regulatory affairs, legal, compliance, quality assurance, and clinical operations is essential for alignment with regulatory requirements.

    Responsibilities:

    1. Coordinate with cross-functional teams to implement regulatory initiatives and quality improvement projects.
    2. Manage regulatory activities for vaccines, biologicals, pharma, bulk drugs, and manufacturing sites with CDSCO.
    3. Secure time-bound approvals and complete submissions for all company projects.
    4. Act as the primary point of contact between the organization and health authorities.
    5. Collaborate with internal departments to ensure alignment with regulatory requirements.
    6. Work with IP commission, NIB, CDTL, or other government laboratories for company projects and products.
    7. Stay abreast of local, state/provincial, and national healthcare regulations.
    8. Facilitate exchange of sensitive and confidential information with Health Authorities.
    9. Advocate for the needs and interests of the organization to health authorities.
    10. Build and maintain positive relationships with key stakeholders.
    11. Support analysis of proposed healthcare policies, legislation, and regulatory changes.
    12. Identify potential compliance risks and develop mitigation strategies.
    13. Collect, analyze, and report data related to regulatory compliance and quality metrics.
    14. Prepare reports and presentations for senior management, regulatory agencies, and other stakeholders.

    Qualifications:

    • Minimum 5 years of experience in regulatory affairs.
    • Experience in managing regulatory activities for vaccines, biologicals, pharma, bulk drugs, and manufacturing sites with CDSCO.
    • Strong understanding of local, state/provincial, and national healthcare regulations.
    • Excellent communication and interpersonal skills.
    • Ability to collaborate effectively with cross-functional teams.
    • Bachelor's degree in a relevant field, advanced degree preferred.

    About Sanofi:

    At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity.

    Let's pursue progress together and discover extraordinary outcomes in healthcare. Join Sanofi and be part of a diverse and inclusive team dedicated to making miracles happen.

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