Executive Director Regulatory Affairs Neuroscience - REMOTE

Remote/New Haven, CT /
Research & Development – Research & Development /
Full-time
/ Hybrid
 The Executive Director Regulatory Affairs will develop the global regulatory strategy with expertise in the Neuroscience/CNS therapeutic area. This individual will have experience in leading project teams for the preparation of pre-IND, EOP2, pre-NDA, etc. briefing documents & meetings with the FDA. The Executive Director Regulatory Affairs will be responsible for IND and NDA documents and will develop regulatory strategy based on new or 505(b)(2) drug development principles, regulatory guidance documents, and by getting input from cross-functional team members.

Job Responsibilities

    • Provides pre-marketing and post-marketing project support
    • Develops global regulatory strategy for compounds in development starting from IND/IMPD to NDA/MAA submissions using experience in regulatory affairs and drug development
    • 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
    • Preparation of regulatory documents such as Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, EMA Scientific Advice documents, DSUR, etc
    • Leads IND maintenance to support all clinical development activities
    • 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 or leads 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
    • Remains current and coaches the regulatory group on regulatory guidance documents from the FDA, EMA, ICH, etc
    • Develops regulatory strategy and oversees implementation. Effectively interprets regulatory guidance and provides recommendations to key stakeholders
    • Actively collaborates with development teams to execute US and global regulatory strategies and contingencies for assigned projects from IND to NDA to post-marketing activities
    • 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
    • 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

Job Requirements

    • Master’s, Pharm D, or PhD Degree in Neurosciences or related discipline preferred
    • 10+ years in pharmaceutical regulatory affairs, including experience in leading project teams through regulatory milestones such as pre IND, EOP2 and other meetings 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
Position will be filled at level commensurate with experience.

Flexible work arrangements may be possible.

Your Path to Endless Opportunities

If you’re looking to push the envelope and join an innovative company where technology meets drug discovery and development and you’re enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of oncology and neuroscience programs, as well as for our partners across major therapeutic areas.

About BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. The Company’s commercial product, IGALMI™ (developed as BXCL501) is a proprietary, sublingual film formulation of dexmedetomidine approved by the FDA for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose. BXCL501 is also being evaluated for the acute treatment of agitation associated with Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder. The Company is also developing BXCL502 as a potential therapy for chronic agitation in dementia and, under its subsidiary OnkosXcel Therapeutics, BXCL701, an investigational, orally administered, systemic innate immunity activator for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.   

EOE/M/F/V/SO
BioXcel Therapeutics is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status.