Regulatory Affairs Director - Permanent - Boston, MA
Proclinical is seeking a Regulatory Affairs Director who will be responsible for the development and execution of regulatory strategies for assigned programs. This is a permanent position based in Boston, MA.
Primary Responsibilities:
The successful candidate will work collaboratively with various teams to bring innovative and compliant approaches to the development and maintenance of our products. This role requires a strategic thinker who can continuously adapt regulatory strategies, provide regulatory input into product profiles, and ensure the flawless execution of global regulatory plans.
Skills & Requirements:
- Advanced degree in a scientific discipline such as Pharmacy, Medicine, Chemistry, Biological Sciences.
- Proven experience in drug development and managing complex worldwide products/projects within a relevant therapeutic area.
- Excellent written and oral communication skills.
- Solid project management skills.
- Strong interpersonal and negotiation skills.
- Strategic thinking and ability to derive creative solutions to regulatory problems.
- Proven ability to lead change and communicate difficult messages effectively.
The Regulatory Affairs Director will:
- Develop and implement regulatory strategies for assigned programs.
- Provide regulatory input into target product profiles and Integrated Asset Strategic Plans.
- Continuously evaluate and adapt development objectives and plans in line with new findings and regulatory requirements.
- Define strategy for regulatory consultation and advocate for proposed strategies to senior leaders.
- Identify potential risks and propose mitigation options.
- Ensure flawless execution and implementation of global regulatory plans.
- Conduct regulatory due diligence assessment on external opportunities.
- Lead operational excellence initiatives within the Regulatory Affairs department.
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) or .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.