Director, Regulatory Affairs

As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a passion to create impactful neuromedicines, with fewer side effects, that allow patients and their families to live healthier and more fulfilling lives.

On a molecular scale, our deep understanding of the intricate relationships between receptors, their associated proteins, and their distributions in specific cell types and brain regions enables us to precisely direct medicines to the neural circuits underlying disease pathophysiology.

Rapport has an exciting opportunity to join our growing regulatory team. This Director of Regulatory Affairs will report directly to the Vice President of Regulatory Affairs and will hold a crucial role developing the regulatory strategy and tactics for assigned programs.

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

Qualifications:

• Bachelors degree in a life science or related discipline
• 10 years of experience in the pharmaceutical industry
• Experience in neurology and small molecules preferred
• Must have experience with submission of new molecular entity INDs. NDA experience preferred but not required.
• Global drug development experience
• Ability to manage competing priorities, influence and integrate within a team, manage timelines, deliver on corporate and program goals.
• Must have good interpersonal skills and fit in with Rapport 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

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

CCPA disclosure notice can be found here.