Regulatory Affairs Manager

Niowave Inc. • Lansing, MI

7d

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level