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ClinchoiceRegulatory Affairs

Senior Associate/Strategist – Regulatory Affairs (APAC CMC)

Bengaluruonsitesenior

via Greenhouse

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About this role

Responsibilities: Authoring regulatory submissions: Writing and reviewing the CMC sections for new e.g. New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs) and lifecycle maintenance regulatory filings including responses to Health Authority’s questions. Ensuring regulatory compliance: Making sure that all documents align with the requirements of regulatory bodies as well as International Council for Harmonisation (ICH) guidelines. Collaborating with subject matter experts (SMEs): Working closely with scientists, quality assurance (QA), manufacturing teams, and regulatory affairs colleagues to gather accurate and complete information about a drug's composition, manufacturing process, and quality control.…

Read the full description on Clinchoice's site →

What we'd score you on

reqspace match rubric

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1

Skills match

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2

Level fit

This role is senior-level. We check your trajectory against it.

3

Domain experience

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4

Recency

A skill you used last quarter weighs more than one from five years ago. We grade on recency, not lifetime.

5

Location fit

This role is based in Bengaluru. We weight your proximity and willingness to relocate.

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