Senior Regulatory Affairs Specialist

ROLE OVERVIEW

We are looking for a hands-on regulatory affairs professional to help shape and validate Zenopsys's AI-driven dossier authoring, review, and submission platform. You will bring deep, practical experience across US and EU filings together with a working command of AI tools, partnering closely with our product and engineering teams to ensure generated content meets health-authority expectations.

KEY RESPONSIBILITIES

• Understand customer data and dossier requirements.

• Configure the Zenopsys AI platform to meet specific customer requirements.

• Own the creation of templates and AI-driven generation of dossiers across dosage forms for US, EU, ACTD,

and other markets.

• Review generated dossiers against applicable regulatory requirements.

• Train customers on using the Zenopsys platform for AI-powered dossier generation and review.

MUST HAVE

1. Atleast 8 years of experience regulatory content authoring experience across highly regulated markets
2. First-time filing experience: hands-on authoring of CMC, review, and submissions for initial filings in the US and EU (e.g., IND, ANDA, NDA, BLA, MAA).
3. Health authority queries: hands-on management, including data gathering and drafting of responses.
4. Source data review: hands-on review of source data from R&D, manufacturing, and related functions.
5. Lifecycle management: demonstrated experience with post-approval lifecycle activities in the US and EU.
6. AI fluency: practical understanding and hands-on experience using AI tools in a professional setting.

GOOD TO HAVE

• Rest-of-World (RoW) submission experience, including ACTD, GCC, and CIS/Russia regions.

IDEAL CANDIDATE PROFILE

• Blend of pharmaceutical company experience and time at a regulatory consulting firm (e.g., Freyr, MASUU,

Genpact).

• Candidates from a regulatory consulting background are strongly preferred.

• Comfortable working independently in a fast-moving, remote-first, AI-native environment.