Head of Regulatory Affairs
Role & Responsibilities
Reporting to our Chief Medical Officer, the Head of Regulatory Affairs is 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 Qualifications We Are Seeking
- 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
Nimbus is a ~ 40 person, biotechnology company located in the thriving biotech hub of Cambridge, Massachusetts. We transform drug development by integrating computational drug discovery techniques, a cutting-edge computational chemistry platform and other advanced technologies to design breakthrough medicines for patients.
We focus on promising targets in metabolic disease, oncology and inflammation. These include both emerging and well-validated targets that have proven intractable to others in the pharmaceutical and biotechnology industry.
Nimbus offers a fast-paced, entrepreneurial, team-focused work environment. The culture is intellectually stimulating, flexible and results-oriented. Joining our Team offers significant opportunities to grow professionally and personally.
We also offer a top-notch benefits package (health, dental, life, vacation, and employer 401K contribution). Being part of Nimbus (a Nimbi, if you’re curious), allows you to become part of a small close-knit professional team that strives to bring out the best in each other by working hard and having fun together (company lunches and outings, running, rocking and even bowling from time to time!)
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.