Senior Manager, Regulatory Affairs

Nimbus has an outstanding opportunity for an exceptional Senior Manager of Regulatory Affairs to join our team.  This role is responsible for the planning, managing and tracking of all regulatory submissions for Nimbus' development programs and maintaining comprehensive plans and reports relevant to major milestones and filing dates.  You will report to our Vice President of Regulatory Affairs.

In this role, you will:

  • Plan, prepare and manage all submissions of regulatory agency applications, reports, and correspondence
  • Facilitate project milestones, tasks, deliverables, key dependencies, and resource requirements
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulations and quality standards
  • Contribute to development and implementation of regulatory affairs policies, processes and procedures to ensure continual compliance and effectiveness
  • Collaborate with CRO(s) and bridge CRO(s) with internal functions to ensure adequate planning and execution of submissions
  • Facilitate preparation and conduct of consultation meetings with health authorities
  • Manage regulatory audits or inspections

These Qualifications Will Help This Role Be Successful:

  • 5+ years experience within regulatory affairs, including direct experience with regulatory submission planning and management
  • Bachelor's degree within life sciences.  Advanced degree preferred.
  • Knowledge of global regulatory submissions and their requirements and guidelines
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Experienced collaborating with CROs and managing relevant deliverables
  • Excellent organizational  and communication (written / verbal) skills.
  • Experienced managing stakeholders and exchanging complex information

 

 

A Snapshot of Nimbus 

Our Science  

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.  

Our Culture 

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.  

Our Company 

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. 

At Nimbus, we believe our diversity of backgrounds and experiences strengthens our community and our ability to design breakthrough medicines. We prioritize creating an inclusive, welcoming culture that promotes our core values and encourages every Nimbi to bring their whole selves to their work. Nimbus is proud to be an equal opportunity employer. We value and celebrate all our employees and recognize that our diversity and inclusion are keys to our success. Nimbus is committed to providing equal opportunity for all employees and applicants without regard to 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.

 

Apply now