Company: BioMarin Europe Limited
Closing Date: 07 Jan 17
Salary (£): Competitive
BioMarin’s Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
Associate Director, Regulatory Research
Reports to (Job Title): Director, Regulatory Affairs
Support senior Regulatory Researchers by compiling and analyzing data and metrics for reports on regulatory pathways and development programs to support US and EU marketing license applications.
Identify the degree of clinical evidence supporting FDA and EMA marketing license applications across several therapeutic areas.
Identify the issues raised during reviews and the approaches used to resolve the issues raised by health authorities.
Perform searches across regulatory agency web sites, reviews, and using available databases to identify regulatory approval, labeling and clinical trial design precedence.
Keep management apprised of FDA and EMA decisions and proposals, regulatory developments, and new regulatory trends.
Generation of regulatory research reports detailing the scope of the search, findings, key messages and conclusions.
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
Substancial experience in the healthcare industry, with a solid background of experience in Regulatory Affairs.
The candidate must have substantial regulatory/clinical Phase I to Phase III development experience.
Extensive research and analytical skills and attention-to-detail is 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 would be beneficial.
Strong collaborative skills, as this position requires close working relationships with both internal 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 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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