Regulatory Affairs Specialist

What the role covers day to day

You will prepare and manage regulatory submissions to the Central Drugs Standard Control Organisation and state licensing authorities, covering new product registrations, renewals, and post-approval changes for the companys India portfolio. You will review labelling, packaging, and promotional material for regulatory compliance before it goes to market, track regulatory timelines against launch plans, and respond to queries and deficiency letters from regulators. You will also monitor changes in Indian pharmaceutical regulation and translate what they mean for the companys existing approvals and pipeline, and coordinate with the global regulatory team on submissions that need to align across markets.

Where this sits

This is a global pharmaceutical company expanding its India hub, and it has partnered with Flexiple, a managed marketplace placing specialist talent inside global companies India teams, to hire this role into its regulatory affairs function.

The right candidate has 3 to 7 years in pharmaceutical regulatory affairs, a background in pharmacy, life sciences, or law with a regulatory focus, and direct experience preparing CDSCO submissions rather than just reviewing them. Comfort working against firm regulatory deadlines matters, as does the judgment to flag a compliance risk to global stakeholders before it becomes a launch delay.

• Location: Hyderabad, Mumbai — on-site, based with the regulatory and quality teams
• Shortlisted candidates go through an HR screening, a technical round with the regulatory affairs lead, and a closing round with hub leadership.
• This application is kept on file for this opening and future regulatory roles Flexiple is placing.