SENIOR DIRECTOR, REGULATORY, CRO, LONDON

We have an opportunity available for a Senior Director of Regulatory, based in London. The position will involve leading the department and is a full-time office based role.

 

Role:

 

 

• Leads and develops a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirement

• Serves as the single point of contact with Sponsor and internal Medpace teams for select projects, with key contributing members from department staff

• Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures

• Accountable for post-market application maintenance and compliance activities

• Partner with department staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally

• Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality

• Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project

• Manage relationships with competent authorities through frequent interaction

• Provide regulatory review of study protocols, investigator’s brochures, labeling, and integrated summary documents

• Collaborate with US regulatory to develop global approval strategies

 

Requirements:

 

• Advanced degree required

• 8+ years of experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas

• Proven leadership and program management experience

• Ability to think strategically and critically evaluate risks to regulatory activities

• Ability to work strategically within a complex, business critical and high profile development program

• Successful contribution to a major regulatory approval at a global or regional level

• A scientific and clinical understanding of the regulatory sciences

Salary dependant on experience and negotiable upon application.

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