Regulatory Affairs Manager
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Job Location:
Lansing, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
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 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
- Bachelors 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 companys 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.
Required Experience:
Manager
