Associate Director, Regulatory Strategy

Rapport Therapeutics; Boston (MA); Hybrid; USD 190,000 - 215,000; Full time

Benefits offered by this job

Unlimited PTO

Lifestyle spending account

Commuting reimbursement

Job summary

Rapport Therapeutics, located in Boston, is seeking an Associate Director of Regulatory Strategy to define regulatory paths for their small-molecule pipeline. This role offers meaningful ownership and the opportunity to influence development decisions within a collaborative startup environment.

The ideal candidate holds a Bachelor's degree in life sciences, has over 10 years of experience in the pharmaceutical industry, and possesses strong leadership skills. This position provides a hybrid work environment and a competitive benefits package, including unlimited PTO.

Qualifications

• 10+ years of experience in the pharmaceutical or biotech industry.
• Experience in neurology and small molecules preferred.
• Global drug development experience.
• Ability to manage competing priorities and integrate within a team.

Responsibilities

• Define the regulatory path for small-molecule pipeline.
• Create innovative regulatory strategies for global drug programs.
• Ensure compliance with submission requirements.
• Mentor and support junior team members.

Skills

Leadership and team building skills

Strong interpersonal skills

Regulatory expertise

Conflict resolution

Exceptional written and verbal communication

Education

Bachelors degree in a life science or related discipline

Tools

Regulatory applications management (INDs, CTAs, NDAs)

Job description

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

As Associate Director, Regulatory Strategy, you'll help define the regulatory path for our small-molecule pipeline, partnering across functions to influence key development decisions. In our collaborative startup environment, you'll have meaningful ownership, direct exposure to leadership, and the opportunity to grow your strategic impact as we advance innovative therapies for patients.

Your Day-to-Day

• 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

Must-Haves

• Bachelors degree in a life science or related discipline
• 10+ years of experience in the pharmaceutical or biotech industry
• Experience in neurology and small molecules preferred
• Global drug development experienceExperience 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

What Makes Rapport Special

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for this role to be $190,000 to $215,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.

Hybrid Work Environment

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

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.