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 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
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.
