Regulatory Affairs Leader
Regulatory Affairs Leader
Nimbus' Regulatory Affairs Leader will be a strategic leader and critical member of Nimbus’ growing Development organization. The individual in this role will lead the strategic direction and operational aspects for Regulatory Affairs, responsible for all regulatory aspects related to CMC, preclinical, and clinical development globally.
This individual will:
- Manage all aspects of the Regulatory Affairs function, including participation in cross-functional team meetings, preparation and submission of regulatory filings, leading regulatory agency meetings, development of policies and procedures, and building appropriate–sized internal resources and managing external resources to implement the strategic plan and meet corporate objectives
- Develop and implement innovative, science-based regulatory strategies highlighting key risks and mitigation measures
- Develop effective working relationships with global regulatory authorities related to the company’s programs
- Provide regulatory guidance and strategic advice to cross-functional teams and company management regarding important development issues, while considering company–wide implications
- Ensure company compliance with respect to all regulatory commitments, obligations, and interactions for FDA and other applicable regulatory agencies
- Ensure timely preparation and submissions in compliance with regulatory requirements to support the conduct of clinical trials and marketing application approvals
- Keep abreast of evolving global regulatory guidance, regulations, or directives. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing or planned development programs.
The following qualifications will help this person be successful:
- Bachelor’s degree in life science or health-related field, advanced degree (preferred)
- 15+ years of global regulatory affairs experience, or 10+ years with advanced degree
- Experience across multiple therapeutic areas, including oncology and/or immunology/inflammation
- Proven experience developing and implementing integrated regulatory strategies and successful regulatory agency interactions
- Deep understanding of the global regulatory landscape, including familiarity with evolving regulations, guidance, and approval precedents pertinent to drug development
- Prior experience leading the preparation and life-cycle management of regulatory submissions, including INDs and CTAs to submission of global dossiers, and serving as the primary interface with FDA and other regulatory agencies
- Experience building and managing internal and external regulatory resources (e.g., regional regulatory consultants, regulatory operations, medical writers)
- Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment
A Snapshot of Nimbus
At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success, we’ve built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.
Nimbus is a close-knit company (our employees are Nimbi, if you are curious!) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.
Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Cambridge, Massachusetts. Learn more about us by going to www.nimbustx.com
Join Nimbus. We are making a difference and you can too.
Nimbus is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.