Senior Director Regulatory Affairs
|Job Title:||Senior Director Regulatory Affairs|
|Contact Name:||Denise Saab|
|Job Published:||February 11, 2019 16:16|
Pension - 3% min by employee, matched by the company to a maximum of 6% and 8% for managers.
25 days holiday + bank holidays and the days over Christmas.
Life Assurance x4 times base salary
Private medical insurance
Season ticket loan
Eye test contribution of up to £25, with a contribution to glasses of up to £50.
Free onsite gym between 7am - 8pm inc swimming pool
Due to a rapidly growing of the clinical activities we are currently seeking a full-time, office-based Senior Director, Regulatory Affairs to join the team. This position will lead OUS Regulatory Affairs and is accountable for the development and implementation of the regulatory strategy for specific Sponsor projects, for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the team.
Leads and develops a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirement.
Experience and knowledge of therapeutic areas and drug development is an important enabler to being able to influence cross-functional discussions Sponsors and relevant stakeholders.
Serves as the single point of contact with Sponsor and internal company teams for select projects, with key contributing members from department staff.
Provide regulatory leadership as needed in early development and due diligence review projects
Advanced degree required. Preferred degrees include, PharmD, MD, and/or PhD. Other degrees and backgrounds may be considered;
>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;
Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions
Broad background of experience working in pharmaceutical business
Successful contribution to a major regulatory approval at a global or regional level
Must demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership, and excellent oral and written communication skills
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