Your impact:

The Senior Manager of Regulatory Affairs will be a key member of the team, supporting the Regulatory Leads of our RAP-219 and other development programs by managing essential tasks such as clinical trial applications, IND submissions, and general regulatory research. 

Your day-to-day:

• Assist in the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) to regulatory authorities
• Manage and contribute to major and routine regulatory submissions, as assigned, including amendments, responses to questions from health authorities, and ensure timely updates to regulatory documents
• Conduct in-depth regulatory research to propose strategic advice on regulatory matters
• Stay up-to-date with regulatory guidelines, policies, and best practices related to clinical trials and drug development
• Monitor regulatory timelines and ensure compliance with all applicable regulations for IND maintenance
• Contribute to the development and continuous improvement of regulatory affairs processes and best practices

Must-Haves:

• Bachelors degree in life sciences or related discipline
• 8+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology
• Proven experience with Global CTA submissions and IND maintenance
• Strong knowledge of regulatory guidelines and clinical trial regulations
• Ability to manage multiple priorities and work in a fast-paced, dynamic environment
• Proficient working with regulatory submission software
• Proactive, self-motivated, and able to work independently
• Strong interpersonal skills and alignment with Rapport’s values and company culture

 

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 Senior Manager level role to be $150,000 to $180,000. 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.