Job Description

We are looking for the regulatory professional who are experienced in the emerging markets for the biologics stream of novel biologics, biosimilars, & the drug-device combination products.

Key responsibilities:

Develop the global regulatory strategies for the novel biologic products across all development phases (preclinical to post-marketing) for the the emerging and ROW markets.
Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, & emerging markets).
Prepare, review, and manage high-quality regulatory submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, etc.
Post-approval changes (variations, amendments).
Liaise with global regulatory agencies to facilitate product approvals and resolve queries.
Collaborate with R&D, Manufacturing, Quality, Clinical, and national regulatory teams to ensure the compliance across product lifecycle.
Monitor and interpret evolving global regulations, guidelines, and industry trends related to product category.
Provide interpretive analyses of regulatory guidance, regulations, or directives that impact product.

Experience:
Master’s in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.
5-7 years of experience in regulatory affairs with a strong focus on biologics and/or combination products.
Understanding of ICH guidelines, FDA, EMA, and regulatory pathways for drug & device combination products.

If you’re passionate about regulatory role for the global market, I’d love to connect or tag someone who fits this profile!

Pls reach out to ramesh.m@microcrispr.com

Location: Vapi, Gujarat.