Posted:
9/18/2024, 7:57:55 AM
Location(s):
Grand Rapids, Michigan, United States ⋅ Michigan, United States
Experience Level(s):
Expert or higher ⋅ Senior
Field(s):
Legal & Compliance
Workplace Type:
Remote
Join BAMF Health, where you're not just part of a team; you're at the forefront of a revolution in Theranostics, changing lives for the better. As a member of our global team, you'll contribute to pioneering technology and deliver top-tier patient care.
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 Head of Regulatory Affairs 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.
Mentorship & Development: Mentor members of the quality team to help develop regulatory knowledge.
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. In lieu of a bachelor’s degree, equivalent GMP/related work experience may be considered.
Minimum of 5 years of related work experience required.
Preferred Qualifications:
Experience in Radiopharmaceutical regulatory affairs preferred.
Regulatory Affairs Certification (RAC) preferred.
8 years of related work experience preferred.
Schedule Details:
Employment Status: Full time (1.0FTE)
Weekly Scheduled Hours: 40
Hours of work: 8:00 am- 5:00 pm
Days worked: Monday to Friday
Location: Grand Rapids, MI (remote opportunity for candidates in TX or MI)
At BAMF Health, our top priority is patient care. To ensure we are able to drive a Bold Advance Medical Future, we offer a well-rounded benefit package to care for our team members and their families. Highlights include:
Employer paid High Deductible Health Plan with employer HSA contribution
Flexible Vacation Time
401(k) Retirement Plan with generous employer match
Several benefit options including, but not limited to; dental, vision, disability, life, supplemental coverages, legal and identity protection
Free Grand Rapids downtown parking
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.
Website: https://bamfhealth.com/
Headquarter Location: Grand Rapids, Michigan, United States
Employee Count: 11-50
Year Founded: 2018
IPO Status: Private
Last Funding Type: Series B
Industries: Artificial Intelligence (AI) ⋅ Biopharma ⋅ Biotechnology ⋅ Clinical Trials ⋅ Health Care