Overview

Reference Number: JO-2106-470043
Director, Regulatory Policy
Rate: Negotiable
Job Type: Permanent
Location: New York

Director, Global Regulatory Policy

New York or Remote

Permanent

This is an exciting and unique opportunity for a Director of Regulatory Policy to take on a new challenge within a company that focuses on changing and enhancing drug development opportunities by capturing real world data to accelerate and generate evidence.

In this role you will help shape regulatory policy and advocacy strategy to support and advance product development and regulatory decision making.

Key Duties:

Provide regulatory policy intelligence, insight and knowledge to internal teams

Drive the company advocacy agenda and form alliances, managing key external relationships to advance regulatory policy.

Evaluate Latest regulatory policy intel and brief internal stakeholders on possible impact to the business.

Develop stakeholder strategy and manage relationships with patient advocates, academics etc.

Propose and respond to draft legislation, regulations, guidelines and policies related to the business offering.

Manages meeting with FDA and other health authorities.

Candidate Requirements:

Regulatory policy expert and leader with a minimum of 5 years federal policy experience within a pharmaceutical or regulatory agency arena.

Able to demonstrate a track record of regulatory policy achievements.

Qualified to Degree standard, ideally an advanced scientific degree or medical degree.

Knowledge of laws, regulations and guidance in relation to medical product development and approval, ideally both the FDA and EMA.

Relative experience within drug development and ideally an understanding of regulations relating to medical software and digital health.

First class communication and time management skills.

A deep understanding of medical products law, regulation and policy making process is key to this role.

To be considered for this opportunity or to request further information please contact Gary.Crawley@cpl.com