Senior Director / Head of Regulatory Affairs
Reviva is a clinical-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system, respiratory and metabolic diseases. Reviva is located in Cupertino, California. For more information, please go to www.revivapharma.com .
Senior Director / Head of Regulatory Affairs will be the leader of the regulatory department and head the regulatory strategy for products across the pipeline. You will be responsible for the regulatory submissions, ensuring all timelines are maintained and company objectives are met.
Essential Duties and Responsibilities:
- Provides leadership on project teams in all areas of regulatory affairs
- Plan and develop the regulatory strategy for all pipeline assets
- Work cross-functionally with various groups (CMC, nonclinical and clinical) to ensure timelines and milestones are met to support the business needs of the company
- Plan, execute, and lead successful regulatory agency meetings and interactions per regulatory strategy
- Oversee all regulatory affairs aspects of regulatory submissions (CTA, IND, NDA etc.) providing the best chance at approval
- Review and approve clinical study protocols, informed consent forms, statistical analysis plans, clinical study reports, investigator brochures, responses to regulatory agencies and all regulatory submissions
- Serve as regulatory liaison with global health authorities, business partners, and CROs
- Understands and maintain knowledge and monitor changes in pertinent laws, regulations and guidance’s and takes a leadership role in assessing and communicating the impact of these requirements to the business
- Advanced science degree (PhD, PharmD, MD, MS), ideally in chemistry, biochemistry, microbiology or life sciences, related field with at least 15 years of experience as a regulatory affairs professional in the biotech/pharma industries.
- Knowledge of relevant regulations, including FDA, EMA, ICH.
- Track record of success on a global scale, receiving regulatory approval on filings at various stages of the drug development cycle
- Extensive experience with small molecules required - CNS experience preferred
- Strong management and interpersonal/communication skills. Prior success in working effectively with cross-functional teams and managing direct reports.
- Ability to effectively present information to top management, and/or boards of directors
- Ability to think strategically and translate into action
- Available to travel if/when needed.