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Regulatory Affairs Manager

Regulatory Affairs Manager
Who we are…
We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living.
Who you are…
You are energized by helping innovative therapies reach patients and take pride in building strategies that navigate complex regulatory environments while supporting scientific progress and business growth. People trust your judgment because you are credible, transparent, and thoughtful in how you balance scientific, regulatory, and organizational priorities.
You communicate clearly with technical experts, executives, partners, and regulators, helping align diverse stakeholders toward a common goal. Above all, you value integrity, quality, and continuous improvement, and you take pride in contributing to work that ultimately improves patient care and advances meaningful scientific innovation.
You are energized by supporting a savvy team that serves every part of the organization. You model a “seek first to understand” environment and celebrate the journey as well as the destination. You wholeheartedly embrace leadership as a choice, a responsibility, and a remarkable privilege to positively impact the lives of others.
What you can expect to work on…
The Manager of Regulatory Affairs will lead the regulatory team by working with key stakeholders to develop strategy for clinical-stage radiopharmaceutical programs transitioning to licensed commercial products. In this role, you will have primary responsibility as an author and contributor to regulatory submissions, as well as building processes and systems that support program and company strategy. This role will regularly interact with global health authorities, and external partners.
  • Develops and executes program regulatory plans and with key stakeholders, build product strategies for clinical assets, licensed products in various regions and jurisdictions to support company growth
  • Leads the regulatory unit and work with partners to file the appropriate regulatory documents (e.g. IND amendments, CTA updates, NDA/BLA submissions, and maintain existing filings) audit responses
  • Prepares, reviews, authors and submits of regulatory dossiers (IND, NDA/BLA, DMFs, variations, amendments)
  • Serves as the primary point of contact for regulatory agencies (FDA, EMA, and other global authorities)
  • Leads health authority meetings, including preparation and presentation of briefing materials, and responses to agency questions
  • Proactively monitors emerging regulatory trends affecting the business and represent the organization by evaluating, interpreting, and providing feedback to regulatory agencies on proposed new or revised regulations
  • Leads regulatory change review assessments to support business scaling and continuous improvements while also assessing changes for partner notifications and impact to current or pending regulatory filings
  • Leads and inspires a diverse team of skilled professionals
  • Establishes and maintains a technical direction and supervisory oversight structure for the department, including career progression and succession planning
What you need to succeed…
  • Bachelor’s degree in science or engineering or related discipline7+ years of Regulatory Affairs experience in biotech, pharmaceuticals, or radiopharmaceuticals
  • Demonstrated experience leading regulatory strategy for clinical programs transitioning to commercialization
  • 3+ years staff management experience, with demonstrated ability to build cohesive teams, establish career development tracks, and succession planning
  • Strong experience with DMFs and CMC-related regulatory submissions
  • Experience and working knowledge of GXP and cGMP quality systems
  • Displays proven ability to lead and develop staff and teams
  • Embraces and models the Niowave Core Values of Teamwork, Courage, Integrity, and Upright Zeal
  • Understands how to integrate into a new team/organization – appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state
  • Displays excellent interpersonal, written, and oral communication skills
  • Possesses strong organizational and project management skills for self and teams
  • Demonstrates strategic thinking with creative and excellent problem solving and decision-making skills with ability to critically interpret and use data to manage risk
Great to have…
  • Advanced Degree in science, business or engineering field
  • Radiopharmaceutical or radioisotope experience
  • Direct experience working in Life Sciences
  • Experience supporting global regulatory filings and approvals for Clinical and Approved Products
  • Experience with 21 CFR Part 210/211, ICH Q1-Q14, and ISO 14971:2019
  • Nuclear Regulatory Commission (NRC) regulations or similar regulatory compliance experience
Other things to know…
  • Full-time position
  • The company’s standard operating hours are Monday thru Friday 6:00 a.m. – 6:00 p.m. with production related activities requiring 24/7/365 shifts
  • This position will have regular working hours Monday - Friday within the standard operating hours
  • There is an expectation of adjusting working hours outside the standard hours to meet operational requirements as needed
  • Niowave has multiple locations within the Lansing area and travel between locations is expected in the role

Please provide a cover letter specifically describing the nature of your background and experience as it relates to this position.

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