Regulatory Affairs Expert Lead
We seek a highly motivated and dedicated individual to join our team as the Head of Regulatory Affairs – EU. This role will involve providing strategic leadership for existing and future portfolio assets, advising internal teams on regulatory matters, performing reviews, and overseeing MLR review committee outcomes.
A key aspect of this position will be effective communication between departments, ensuring fast and efficient collaboration. The successful candidate will have significant responsibility and autonomy in their work contributions.
Duties
- Provide EU regulatory strategy leadership for existing and future portfolio assets
- Advise internal teams on management regulations guidance industry best practices Perform regulatory reviews work cross-functional leaders facilitate discussions evaluate regulatory risks Oversee MLR review committee outcomes Coach mentor team changing regulatory environment new regulations guidance enforcement Recruit develop advisor coach direct reports junior members Regulatory team Qualifications Education Requirements Bachelors degree Life Science related disciplines 15+ years Regulatory experience Thorough understanding EU Regulatory landscape Proven experience leading dynamic teams fostering culture efficiency teamwork Demonstrated track record successful product launches Excellent organizational interpersonal verbal written communication skills Strong network working rapport with external partners such as third-party consultants Ability adapt changing circumstances requiring flexibility empathy sense urgency Azurity Pharmaceuticals Equal Opportunity Employer