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Located in the heart of downtown Grand Rapids, our cutting-edge global headquarters resides within the state-of-the-art Doug Meijer Medical Innovation Building. Step into our modern and spacious facilities, where innovation thrives and collaboration knows no bounds.

Join us in our mission to make Theranostics accessible and affordable for all, and be part of something truly remarkable at BAMF Health.

BAMF Health is seeking an experienced Regulatory Affairs Lead to spearhead the development and execution of regulatory strategies across our Radiopharmacy operations. This role is essential for ensuring compliance with state and federal regulations while supporting the growth and expansion of our manufacturing capabilities. The ideal candidate will possess deep regulatory expertise and strategic acumen, particularly in guiding the regulatory aspects of new and existing facilities and ensuring alignment with our broader corporate objectives.

Duties and Responsibilities, including but not limited to:

• Regulatory Strategy Development: Lead the development of a robust regulatory strategy that aligns with BAMF Health’s growth objectives, including the expansion of manufacturing capabilities. Ensure all regulatory activities are strategically planned and executed to meet corporate goals.
• Facility Compliance & Oversight: Provide regulatory oversight for both new and existing manufacturing facilities, ensuring all operations comply with relevant state and federal regulations. Work with facility teams to maintain ongoing compliance and address any regulatory challenges.
• Cross-Functional Collaboration: Collaborate with senior management, R&D, operations, and facility teams to integrate regulatory considerations into business planning and facility operations. Ensure that regulatory strategies are well-coordinated across all departments.
• Regulatory Landscape Analysis: Monitor and analyze the regulatory environment to anticipate changes and adjust strategies accordingly. Focus on maintaining a proactive approach to regulatory challenges and opportunities, particularly in the context of expanding operations.
• Regulatory Submissions & Approvals: Oversee the preparation and submission of all regulatory filings, ensuring that they meet the highest standards of accuracy and compliance. Manage relationships with regulatory agencies to facilitate timely approvals and ongoing compliance.
• Risk Management & Mitigation: Identify potential regulatory risks associated with both ongoing operations and new initiatives. Develop mitigation strategies to address these risks and ensure business continuity.
• Regulatory Influence & Advocacy: Represent BAMF Health in regulatory discussions, advocating for favorable outcomes on key regulatory issues. Build and maintain strong relationships with regulatory agencies to support the company’s interests.
• Team Leadership & Development: Build and mentor a high-performing regulatory team, fostering a culture of strategic thinking and continuous improvement. Ensure that the team is well-equipped to support the company’s regulatory needs across all facilities.
• Process Improvement & Innovation: Identify opportunities for innovation and process improvements within the regulatory function, particularly in the context of expanding manufacturing capabilities. Drive initiatives that enhance regulatory efficiency and effectiveness.
• Other responsibilities as required.

Basic Qualifications:

• Bachelor’s degree in Regulatory Affairs, Life/Physical Sciences or a related field required. In lieu of a bachelor’s degree, equivalent GMP/related work experience may be considered.

• Minimum of 8 years of related work experience required

Preferred Qualifications:

• Experience in Radiopharmaceutical regulatory affairs preferred.

• Regulatory Affairs Certification (RAC) preferred.

BAMF Health is an Equal Opportunity Employer and will not accept or tolerate discrimination or harassment against any applicant, employee, intern, or volunteer based upon the following characteristics: race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability or handicap, sexual orientation, gender identity/expression, transgender status, genetic information, pregnancy or pregnancy-related status, marital status, veteran status, military service, any application for any military service, or any other category or class protected by applicable federal, state, or local laws.