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Global Regulatory Affairs

5 - 9 years

0 Lacs

vapi gujarat

Posted:5 days ago| Platform: Shine logo

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Skills Required

ema regulatory submissions maa cta annual reports rd quality clinical regulatory compliance product development tech transfer biologics mabs biosimilars vaccines regulatory strategies biologic products fda inds impds bla dsur postapproval changes global regulatory agencies national regulatory teams clinical trial execution global regulations ich guidelines novel biologics lifecycle management

Work Mode

On-site

Job Type

Full Time

Job Description

As a Regulatory Affairs Manager for biologic products, your responsibilities will include: - Developing global regulatory strategies for biologic products throughout all development phases in the US, EU, and rest of the world, ensuring alignment with business objectives and regulatory requirements in different regions (FDA, EMA, emerging markets). - Preparing, reviewing, and managing high-quality regulatory submissions such as INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, and post-approval changes (variations, amendments). - Engaging with global regulatory agencies to support product approvals and address inquiries, collaborating with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance during the product lifecycle. - Providing regulatory advice during product development, technology transfer, and clinical trial execution, monitoring and interpreting evolving global regulations, guidelines, and industry trends related to the product category, and offering interpretive analyses of regulatory guidance impacting product(s) or CMC operations. To qualify for this role, you should have: - A Master's degree (M.Sc./M.Pharm/M.Tech) in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field. - At least 5-7 years of regulatory affairs experience with a focus on biologics like mAbs, biosimilars, vaccines, or novel biologics in emerging markets. - A strong understanding of ICH guidelines, FDA, EMA, and other regulatory frameworks in emerging markets, along with experience in IND/BLA submissions and lifecycle management of biological products.,

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