What are the responsibilities and job description for the Associate Director/Director, Regulatory Affairs position at Fairway Consulting Group?
Our client is a biopharmaceutical company. They have asked us to assist them in their search for an Associate Director / Director, Regulatory Affairs.
Major tasks and responsibilities include :
- Develops and implements innovative global regulatory strategies to maximize the likelihood of regulatory success across multiple regions (US, EU, Asia-Pacific).
- Integrates the European regulatory, legal, scientific / medical and business perspectives to achieve the optimal regulatory outcomes in accordance with company objectives.
- Plans and executes submission strategy for major regulatory dossiers to the FDA and / or EMA.
- Actively participates in regional organizational activities across projects.
- Conducts regulatory risk planning and mitigation.
- Supports planning and maintenance of the regulatory budget.
- Participates in key interactions with health authorities and communicates health authority feedback to drug discovery and clinical development teams.
- Develops and maintains practices and procedures of Global Regulatory Affairs team.
- Remains up to date on the global regulatory environment, regulations, and guidance (in the NA and EU regions).
- Maintains knowledge of the disease areas.
- Participates in due diligence activities and alliance management for partnered programs.
- Watches, anticipates, and acts on trends and changes in the European and international regulatory environment which may have an impact on the business.
- Develops and maintains strong functional relations with regulatory vendors across multiple regions.
We seek candidates with the following qualifications :
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon's list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms .
