Global Regulatory Affairs

7 days ago

Vapi, India Meril Full time

Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory submissions includingINDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable.4. Post-approval changes (variations, amendments).5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries.6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensureregulatory compliance across product lifecycle.7. Provide regulatory guidance during product development, tech

  • Global Regulatory Affairs

    7 days ago

    Vapi, India Meril Full time

    Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...

  • Global Regulatory Affairs

    1 week ago

    Vapi, India Meril Full time

    Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...

  • Global Regulatory Affairs

    7 days ago

    vapi, India Meril Full time

    Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...

  • Global Regulatory Affairs

    6 days ago

    Vapi, India Meril Full time

    Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...

  • Global Regulatory Affairs

    6 days ago

    Vapi, India Meril Full time

    Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...

  • Global Regulatory Affairs

    5 days ago

    Vapi, India Meril Full time

    Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...

  • Global Regulatory Affairs

    7 days ago

    Vapi, India Meril Full time

    Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory...

  • Global Regulatory Affairs

    7 days ago

    Vapi, India Meril Full time

    Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory...

  • Urgent! Global Regulatory Affairs

    5 days ago

    Vapi, India Meril Full time

    Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory...

  • Global Regulatory Affairs

    6 days ago

    Vapi, India Meril Full time

    Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...