Overview

Reference Number: JO-2106-470042
Senior Director Global Regulatory Affairs Strategy
Rate: Negotiable
Job Type: Permanent
Location: New York

Senior Director, Global Regulatory Affairs Strategy

New York / Remote

Permanent

This is an outstanding opportunity for a Senior Director, Global Regulatory Affairs Strategist to join a unique business focused on making an impact in drug development on a much wider scale.

As the Senior Director, Global Regulatory Affairs Strategy, your role will focus on leading the global regulatory affairs strategy through drug development project works and in collaboration with health authorities via research initiative work. The role demands an individual with a deep understanding of drug development strategy and operations.

Key Duties:

Guide regulatory strategy for research initiatives and sponsor work.

Develop, implement and manage the global regulatory strategy inline with company objectives and strategy.

Ensure adherence to regulatory reporting obligations and requirements (including pharmacovigilance) and support processes and audit functions/interfaces to correctly implement responsibilities.

Provide support with regulatory submissions and undertake regulatory project management and writing duties.

Candidate requirements:

You will be a regulatory science expert with experience in drug development within the biopharmaceutical industry.

Youll be excited by the prospect of rolling up your sleeves to tackle meaningful problems with a forward thinking approach.

Hold an advanced degree (PharmD, PhD, MD) or hold extensive experience with a BA, BS or equivalent.

Sound knowledge of IND/CTA through BLA/NDA/MAA submission requirements with the FDA and EMA.

Able to demonstrate knowledge across all stages of drug development, compliance & documentation.

Expertise gained in ICH, FDA and EMA statutes, guidelines, initiatives governing regulatory compliance and reporting.

Proven leaderships and interpersonal skills with the ability and passion to lead teams.

Able to manage multiple projects simultaneously within a fast paced environment.

To be considered for this opportunity or to arrange a briefing call please contact Gary.Crawley@cpl.com