Senior Regulatory Affairs Associate

About Company:

Our client is a leading global biopharmaceutical services company that supports pharmaceutical and biotechnology companies in developing new medicines. It provides services such as clinical trial management, regulatory support, consulting, and commercialization. As a Contract Research Organization (CRO), Company helps conduct clinical research and supports the drug development process across different therapeutic areas and countries. The company works with healthcare and life-sciences organizations to help bring new and innovative treatments to patients.

An Ideal Candidate:

Ideal candidate should have Bachelor’s degree in Life Sciences, Pharmacy, or related qualification with

Minimum 4+ years of industry experience with pharmaceutical/ CRO companies. Experience should be in Clinical Trial Application submissions (EU CTR & ROW) also Strong project management experience in a global/matrix environment.

Key Competencies:

1. Lead end-to-end CTA project management across multiple studies and countries
2. Plan, track, and deliver submissions aligned with timelines and regulatory requirements
3. Manage risks, dependencies, and complexities in global regulatory environments
4. Apply knowledge of EU CTR and ROW CTA requirements
5. Manage core clinical and regulatory documentation
6. Collaborate with cross-functional global teams
7. Build and maintain stakeholder relationships and resolve conflicts
8. Monitor KPIs related to timelines and deliverable quality
9. Identify risks and lead quality investigations as needed