Senior Director, Regulatory Research - United Kingdom
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- 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
- 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
- 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.