Remote Regulatory Affairs Generalist | IND/NDA Expert

Parexel; Dover; Remote; GBP 80.000 - 110.000; Vollzeit

Zusammenfassung

Parexel in the United Kingdom is seeking a Regulatory Affairs Consultant - Generalist to provide end-to-end regulatory support for strategic partnerships, covering IND maintenance, health authority interactions, NDA submissions, and post‑approval commitments. You will combine hands‑on Module 1 authoring and submission management with regulatory intelligence, meeting support, lifecycle maintenance, and cross‑functional coordination across assets and alliances.

The role requires strong U.S.

Qualifikationen

• 5+ years of regulatory affairs experience in pharma/biotech.
• Hands-on IND Module 1 authoring and NDA experience.
• Experience with FDA interactions and post-approval regulatory lifecycle.
• Ability to translate guidelines into concise decision-oriented presentations.
• Excellent written and verbal English; cross-cultural communication.

Aufgaben

• Lead or support IND Module 1 and NDA submissions with accurate tracking.
• Coordinate health authority meetings and responses.
• Maintain lifecycle submissions including updates and annual reports.
• Prepare Global Regulatory Team materials and align cross-functional inputs.
• Ensure inspection-ready regulatory documentation and records.

Kenntnisse

Regulatory writing

Submission management

Cross-functional collaboration

Project management

Attention to detail

Ausbildung

Bachelor’s degree in a scientific field

Tools

RIM

EDMS

Jobbeschreibung

Parexel in the United Kingdom is seeking a Regulatory Affairs Consultant - Generalist to provide end-to-end regulatory support for strategic partnerships, covering IND maintenance, health authority interactions, NDA submissions, and post‑approval commitments. You will combine hands‑on Module 1 authoring and submission management with regulatory intelligence, meeting support, lifecycle maintenance, and cross‑functional coordination across assets and alliances.

The role requires strong U.S.