Company: BioMarin Europe Limited
Closing Date: 07 Jan 17
Salary (£): Competitive
BioMarin’s Commercial organization supports our global sales and marketing efforts around the world. Our global sales force continues to solidify the company’s commercial presence in the United States and Europe and is rapidly growing in other regions, such as Latin America, the Middle East and Asia-Pacific. Come join our team and make a meaningful impact on patients’ lives.
Director, Regulatory Research
Reports to (Job Title): Sr. Director Regulatory Research
Investigate and analyze regulatory precedence for FDA and EMA marketing application approvals across several therapeutic areas.
Evaluate the totality of evidence used to support FDA and EMA marketing applications.
Highlight and address, agency review comments, issues and trends that may be relevant to BioMarin development programs.
Provide recommendations to project teams and senior management on regulatory pathways and development programs including clinical trial designs to support license marketing applications and applications for investigational products.
Evaluate the impact of changes in the regulatory environment and regulatory trends.
Keep senior management apprised of the implications of FDA and EMA regulatory decisions and proposals.
A PharmD or PhD in a life science is required.
Experience in the healthcare industry, including experience in Regulatory Affairs is required.
The candidate must have substantial regulatory/clinical Phase I to Phase III development experience.
Extensive research and analytical skills and attention to details are essential to thoroughly research and document the details of the development programs.
Experience in identifying trends in regulatory research information.
Experience in European Regulatory Affairs and procedures is beneficial.
Proven ability to identify unique and creative regulatory strategies appropriate for the FDA and EMA approval of both biologics and small molecules is an essential requirement.
Strong collaborative skills, as this position requires close working relationships with both internal and external stakeholders.
Experience in using regulatory data bases (e.g. Cortellis, Pharmapendium) would be a plus.
Excellent verbal, written and presentation skills.
The candidate must interact with regulatory research and other internal team members, senior management, regulatory affairs representatives, and potentially industry organizations.
Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
All employment offers and resumes are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at BioMarin requests that recruiters are not to contact BioMarin employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with BioMarin.
BioMarin will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of BioMarin.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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