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Senior Director, Regulatory Research - United Kingdom
Posted on : 13 May 2017
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’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.
- 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 company 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.
- Reviewing key RR reports
A PharmD or PhD in a life science is required.
- Experience in the orphan healthcare industry and extensive experience in Regulatory Affairs is required
- The candidate must have substantial regulatory/clinical Phase I to Phase III development experienced
- 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.
- Clinical experience is essential
- Orphan Drug experience is also essential
- Line Management
- Strong due diligence experience
- KOL Ad Board experience/ interactions
There will be line management, experience leading a team is desirable
- 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 company requests that recruiters are not to contact company employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with the company.
- Our company 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 our company.
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.