Director, Regulatory Strategy
About The Position
When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we’re driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we’re doing this with extraordinary science and awesome people (affectionately called Rapptors). Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder. The strength of Rapport comes from our Rapptors – who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you’re as excited about this opportunity as we are! Your Impact: The Director of Regulatory Strategy will play a pivotal role in leading strategic regulatory initiatives for assigned drug development programs.
Requirements
- Bachelors degree in a life science or related discipline
- 12+ years of experience in the pharmaceutical or biotech industry
- Global drug development experience
- Experience working with DAAP or Neurology FDA Divisions
- Ability to manage competing priorities, influence and integrate within a team, manage timelines and deliver on corporate and program goals.
- Strong interpersonal skills and alignment with Rapport’s values and company culture
- Must demonstrate strong leadership and team building skills, including experience with conflict resolution and real time problem solving.
- Thorough understanding of the development phases within a fast-moving biopharmaceutical organization.
- Exceptional written and verbal communication skills
Nice To Haves
- Experience in neurology and small molecules preferred
Responsibilities
- Create and implement innovative and effective regulatory strategies to support the development of Rapport global drug development programs
- Provide regulatory expertise and advise to cross-functional team members including clinical, CMC, clinical pharmacology, and nonclinical
- Accountable for the maintenance of regulatory applications such as INDs, CTAs, NDAs, etc.
- Identify regulatory risks and mitigation plans
- Serve as the regulatory lead on project teams
- Ensure compliance with local and international submission requirements, manage CROs as applicable.
- Represents Rapport as the point of contact for regulatory health authorities, as assigned ensuring exemplary ethics and transparency within the company and with health authorities
- Keeps current with global regulatory landscape and advises project teams on potential impact to programs
- Provide mentorship and support to junior team members to foster their professional growth and development
Benefits
- Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
51-100 employees
