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    Regulatory Cmc & Devices Lead

    Sanofi
    8+ years
    Not Disclosed
    Hyderabad
    10 Dec. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Regulatory CMC and Devices Lead
    Location: Hyderabad
    Job Type: Full-time

    About Sanofi

    Sanofi is a global healthcare leader, committed to advancing progress in the pharmaceutical and healthcare sectors. We aim to create extraordinary outcomes in science and medicine. We are looking for passionate individuals who want to chase change, embrace new ideas, and explore opportunities to make miracles happen.

    Key Accountabilities:

    As the Regulatory CMC and Devices Lead, you will play a pivotal role in ensuring the successful development, regulatory strategy, and lifecycle management of healthcare products including chemical and biological entities, devices, and other health-related products. Your responsibilities will include:

    Strategic Leadership:

    • Represent Global Regulatory Affairs (GRA) CMC (Chemistry, Manufacturing, and Controls) in cross-functional teams, facilitating the development and lifecycle management of products, ensuring alignment with regulatory requirements.
    • Develop global CMC regulatory strategies for products in the re-development phase, as well as for ongoing maintenance during their lifecycle.
    • Contribute to Clean Ingredients and Sustainability initiatives within the company, ensuring regulatory alignment with these strategies.

    Regulatory Submissions and Strategy:

    • Plan submissions and CMC dossier/package strategies according to global regulatory requirements, covering submissions such as CTA/INDs, MAAs, international MAs, HA meetings, and change amendments/supplements.
    • Provide timely and accurate CMC assessments and regulatory input to cross-functional teams.
    • Facilitate the dossier preparation, review, and publishing process in line with project timelines and regulatory expectations.
    • Ensure high-quality filings and secure timely approvals for regulatory submissions.

    Stakeholder Engagement and Risk Management:

    • Collaborate closely with CMC, Manufacturing & Supply teams to develop positive relationships and ensure successful regulatory implementation.
    • Lead Health Authority (HA) meetings, acting as a Subject Matter Expert (SME) and supporting strategic negotiations to ensure successful outcomes.
    • Identify and communicate regulatory risks for major CMC activities, taking necessary steps for mitigation.

    Regulatory Intelligence and Compliance:

    • Contribute to Regulatory Science and Policy activities, staying updated on changes to local and international Health Authority regulations and guidelines.
    • Support Health Authority inspections as required, ensuring effective communication regarding CMC regulatory questions.
    • Lead efforts to ensure alignment with current and future Health Authority thinking and regulatory trends.

    Mentorship and Leadership:

    • Provide leadership and mentoring to staff within the Regulatory CMC team.
    • Take initiative in training and developing junior staff, promoting knowledge sharing across teams.

    Skills, Experience & Knowledge Requirements:

    Education:

    • Master’s degree or equivalent in Pharmacy, Chemistry, Biological/Biotechnology Sciences, or related field. An advanced degree (Master’s or PhD) is preferred.

    Required Experience:

    • 8+ years of relevant experience in Regulatory CMC, with a focus on global CMC regulations.
    • Experience in developing regulatory CMC strategies for medicinal products, with a preference for candidates with additional experience in technical pharmaceutical CMC (e.g., laboratory, development, manufacturing).
    • Knowledge or experience in Probiotics, Food Supplements, and Medical Devices will be advantageous.
    • Global Regulatory CMC experience is essential. Experience working with Regulatory Health Authorities is a plus.

    Other Characteristics:

    • Strategic thinker with strong interpersonal and communication skills.
    • Ability to work in a highly matrixed environment and demonstrate strong teamwork.
    • Self-motivated with an entrepreneurial spirit and a "think outside the box" mindset.
    • Ability to mentor and train junior staff, fostering an environment of knowledge sharing.
    • Excellent oral and written presentation skills.

    Technical Skills:

    • Proficiency in Veeva Vault RIM and other digital tools such as MS Word, Excel, PowerPoint, SharePoint.
    • In-depth knowledge of global CMC regulations and guidelines.

    Language Skills:

    • Fluency in English (both oral and written) is essential.

    Why Sanofi?

    At Sanofi, we offer a dynamic, collaborative, and inclusive environment where people are empowered to contribute to innovative healthcare solutions. Join us as we pursue progress and discover extraordinary together!

    Equal Opportunity Employer:
    Sanofi is committed to providing equal opportunities to all employees, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

    Pursue Progress. Discover Extraordinary.
    Be part of a team that is dedicated to improving global healthcare and making a meaningful impact.

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