We anticipate hiring for this role in mid-Q4. The preferred location for this role is in Boston, MA with an onsite requirement of Monday-Wednesday every week.
Your impact:The Associate Director/Director of Regulatory Strategy will play a pivotal role in leading strategic regulatory initiatives for the bipolar indication of our lead program, RAP-219.
Your day-to-day: - Create and implement innovative and effective regulatory strategies to support the development of Rapport late stage global drug development programs
- Provide regulatory expertise and advice to cross-functional team members including clinical, clinical pharmacology, and nonclinical
- Accountable for the maintenance of regulatory applications such as INDs, CTAs, NDAs, etc.
- Identify regulatory risks, propose mitigation plans and communicate impact to senior leadership.
- Serve as the regulatory lead on study teams, as assigned, and provide regulatory guidance regarding clinical development plans, trial design, endpoints, safety requirements, and submission strategy.
- Ensure compliance with local and international submission requirements, manage regulatory CROs as applicable.
- Represent Rapport as the point of contact for regulatory health authorities, as assigned, ensuring exemplary ethics and transparency within the company and with health authorities.
- Lead preparation and execution of interactions with FDA, EMA, and other regulatory agencies include the coordinate meeting requests, briefing documents, and responses to regulatory questions.
- Monitor and interpret evolving global regulatory landscape and advise project teams on potential impact to programs
- Support portfolio planning and governance activities as needed.
Must-Haves:- Bachelor's degree in a life science or related discipline
- 8-10 years of experience in the pharmaceutical or biotech industry, with significant Regulatory Affairs experience
- Experience small molecule drug development preferred
- Global drug development experience preferred
- CNS experience, in particular psychiatric or neurology indications preferred
- 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 the role to be $200,000 to $225,000. 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 Monday-Wednesday to create more opportunities for innovation, collaboration, and connection.
