Our client is a clinical stage biopharmaceutical company which is utilizing a novel Artificial Intelligence platform to identify and develop medicines for neuropsychiatric and oncology indications. They are seeking a Regulatory Affairs Senior Director or Executive Director who can develop and lead clinical regulatory strategies for a portfolio of CNS programs and work directly with health authorities. This company offers a collaborative company culture and the ability to work from home with regular visits to the office. With their lead candidate in Phase 3, now is an exciting time to join this growing organization and help patients in need.
- Develop, lead, and direct global regulatory strategies for a portfolio of clinical-stage CNS programs from IND to NDA and post-marketing activities.
- Lead the development and preparation of regulatory documents, with input from global product team members. This includes INDs, NDAs, MAAs, Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, EMA Scientific Advice documents, etc.
- Lead and represent the company in regulatory health authority meetings. Assist with the preparation of Type B or C meeting documents, meeting requests, meeting packages, etc.
- Lead IND maintenance to support all clinical development activities.
- Create, maintain, and execute regulatory project plans, timelines, and other tools required to facilitate planning and coordination of deliverables for each assigned project.
- Manage and participate in post-approval global product activities including product complaints, supplements and variations leading to labeling updates.
- Oversee and assist in the preparation and review of responses to global health authorities.
- Review and edit technical documents provided by the clinical, clinical pharmacology and nonclinical functions and extract information necessary for regulatory submissions.
- Interpret regulatory guidance and provides recommendations to key stakeholders. Remain current and coach the regulatory group on regulatory guidance documents from the FDA, EMA, ICH, etc.
- Ensure adherence to relevant regulatory guidance and regulations, as well as company Standard Operating Procedures (SOPs).
- Bachelor’s degree in a scientific field. Advanced degree, such as PharmD, PhD, MS preferred.
- Ten or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
- Must have regulatory experience with CNS/neuroscience programs.
- Strong knowledge of drug development and regulatory policy.
- Experience developing and leading regulatory strategies for INDs, CTAs, NDAs, and/or MAAs.
- Strong knowledge of biopharmaceutical industry Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations.
- Knowledge of clinical development, including responsibilities for successful management of development milestones and marketing authorization, meeting facilitation, deficiency letter and regulatory responses.
- Strong interpersonal skills with the ability to negotiate and influence others in a positive and effective manner, with or without direct authority.
- Must be collegial, collaborative and open to feedback from others across the organization.
- Ability to make decisions, think critically, solve problems and respond proactively.