The Executive Director, Regulatory Affairs will report to the SVP & Head, Translational Medicine, Clin. Pharm. & Reg. Affairs.
The Executive Director, Regulatory Affairs will be responsible for developing and executing the global regulatory strategy for one or more projects. This individual will, with a high sense of urgency, provide strategic and operational regulatory input to cross-functional teams responsible for global development programs. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
Responsibilities and Duties
Provide a bullet point list of the responsibilities and duties of this job.
- Using experience in regulatory affairs and drug development, prepares global regulatory strategy for compounds in development starting from IND/IMPD to NDA/MAA submissions.
- Leads the development and preparation of regulatory documents, with input from global product team members. Documents must meet current regulatory standards (for e.g. FDA, EMA, MHRA, etc) and must be of high quality, consistent, and approvable by regulatory authorities. This includes, but may not be limited to, IND, Type B or C meeting documents, EOP2, NDA/MAA documents prepared in the electronic Common Technical Document (eCTD) format,
- Responsible for the preparation of regulatory documents such as Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, EMA Scientific Advice documents, etc
- Prepared DSUR and/other documents to meet annual reporting requirements
- Leads IND maintenance to support all clinical development activities.
- Manages and participates in post-approval, global product activities. This includes, but may not be limited to, change control, product complaints, supplements and variations leading to labeling updates.
- Works with the team to develop a timeline for responding to regulatory inquiries from global regulatory agencies to ensure issues are addressed in a timely manner. Assists in the preparation and review of responses to global health authorities.
- Participates in regulatory health authority meetings and assists with the preparation of meeting request, meeting packages and summaries/minutes.
- Reviews and edits technical documents provided by the clinical, clinical pharmacology and nonclinical functions and extracts information necessary for regulatory submissions. This may also involve recommending changes to technical documents to ensure conformance with existing regulatory approvals.
- Remains current on regulatory guidance documents from the FDA, EMA, ICH, etc.
- Directs regulatory strategy development and implementation for allocated products. Effectively interprets regulatory guidance and provides recommendations to key stakeholders.
- Actively collaborates with development teams to execute US regulatory strategies and contingencies for assigned projects from IND, to NDA to post-marketing activities. Plans and manages regulatory activities, including the development and maintenance of regulatory budgets and timelines. Ensures adherence to relevant regulatory guidance and regulations, as well as company Standard Operating Procedures (SOPs). Participates in decision-making and risk-management process.
- Creates, maintains, and executes regulatory project plans, timelines, and other tools required to facilitate planning and coordination of deliverables for each assigned Project. Facilitates the development of the integrated project plans relevant to the regulatory deliverables and ensures alignment across relevant functions and smooth transitions among pipeline stages. Facilitates contingency and risk mitigation planning.
- Interacts with head of regulatory and other Sr. Management / executive levels. Exercises judgment and exerts influence on the overall objectives and long-range goals of assigned projects. May represent the department in relevant internal/external committees.
- Responsible for development and implementation of regulatory strategies for BXCL501 dementia, opioid withdrawal and follow up programs
- Responsible for the development an implementation of regulatory strategies for BXCL701 including strategies for neuroendocrine prostate cancer and pancreatic cancer
- Manages regulatory operations for programs under management
- At least 15 years in pharmaceutical industry regulatory affairs, including experience in leading regulatory teams and participating in cross-functional development teams.
- Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
- Experience in all phases of development across multiple therapeutic areas including IND, NDA, and CTA experience.
- Master’s, Pharm D, or PhD Degree in a related discipline