The Executive Director, Regulatory Strategy will be accountable for developing and executing the global regulatory strategy with expertise in neurosciences/CNS therapeutic areas. This individual will have experience in leading teams for the preparation pre-IND, EOP2, pre-NDA, etc. briefing documents & meetings with the FDA. The Executive Director, Regulatory Strategy will be accountable and responsible for IND and NDA documents and lead a small team of regulatory affairs professionals. This individual will, with a high sense of urgency, develop regulatory strategy based on new and 505(b)(2) drug development principles, regulatory guidance documents, and by getting input from cross-functional team members. This individual will also be responsible for providing regulatory input to cross-functional teams responsible for global development programs. Moreover, the incumbent will also understand and act on corporate goals, ensure effective communication, and develop constructive working relationships with team members and representatives of regulatory authorities.
Lead a team of regulatory affairs colleagues supporting pre-marketing and post-marketing project support
Prepares global regulatory strategy for compounds in development starting from IND/IMPD to NDA/MAA submissions Using experience in regulatory affairs and drug development.
Develops and executes a clear plan for working with the team for the preparation of regulatory documents
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 IND, Type B or C meeting documents, EOP2, NDA/MAA documents prepared in the electronic Common Technical Document (eCTD) format,
Accountable and responsible for the preparation of regulatory documents such as Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, EMA Scientific Advice documents, etc.
Accountable for 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 requests, 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 and coaches the regulatory group on regulatory guidance documents from the FDA, EMA, ICH, etc.
Leads and represents the company at meetings with regulators
Leads and directs regulatory strategy development and implementation. 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).
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 Sr. Management / executive levels. Exercises judgment and exerts influence on the overall objectives and long-range goals of assigned projects. Will represent Regulatory Affairs in relevant internal/external committees.
Accountable for development and implementation of regulatory strategies for BXCL501 in dementia, delirium, opioid withdrawal, and other neuroscience programs
Accountable for the development of regulatory strategies for the oncology portfolio
Experience in developing regulatory strategy for oncology indications
Experience in developing regulatory project plans for key deliverables that integrate with overall development plans
Experience in developing and submitting European regulatory documents including Scientific Advice, PIP, pre-MAA and MAA submissions
Experience in risk-management process
At least 10 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
Education: Master's, Pharm D, or PhD Degree in Neurosciences or related discipline
BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI's drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI's two most advanced clinical development programs are BXCL501, an investigational sublingual thin film formulation in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator in development for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents.
For more information, please visit www.bioxceltherapeutics.com.