Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality

Required Knowledge, Skills, and Experience

• Education: Bachelor’s degree in a scientific, engineering, or regulatory discipline (e.g., CMC); MS or PhD preferred.

• Experience: Minimum five years of experience in Regulatory Affairs related to  FDA oversight of various human medical products (HCT/Ps, drugs and/or biologics, medical devices, and combination products)developing regulatory deliverables and submissions. Work experience must include project management and/or managerial experience.

• Other:

  • An understanding of FDA regulations, clinical development and data analysis is required.

  • Possesses US and/or International regulatory experience/fluency with regulations , standards, and guidance documents (e.g., FDA, ICH, ISO).

  • Domain-specific regulatory expertise in regenerative medicine or other MCRA areas of regulatory and scientific expertise.

  • Understanding of your team's regulatory landscape, including the breadth of products, services, how they interact, and how data flows between deliverables.

  • Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

  • Possesses strong written, including medical/technical writing, and verbal communication and presentation skills.

  • Possesses a multi-disciplinary understanding of engineering and a biological sciences to assist with non-clinical and clinical strategies and is able to effectively communicate these strategies to internal team members and clients.

  • Able to creatively think through potential solutions and put the solution skillfully on paper.

  • Strong research, analytical, critical-thinking and problem-solving skills.

  • Strong professionalism with customer relations and managing client relationships.

  • Ability to lead a team effectively, mentor junior team members, and is accountable for team reaching target utilization, as required.

  • Able to lead multiple projects with competing deadlines; takes initiative and ownership of results; demonstrates a high-level of self-accountability.

  • Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.

  • PC/Technical skills- MS Office, Excel, Word, PowerPoint.

  • Must be punctual, polished, and professional.

  • Effective interpersonal skills: shows confidence with subject matter and “calm under pressure” approach and style.

  • Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.

• Develop and execute regulatory services for client companies, including however not limited to:

  • Regulatory Submissions (e.g., IND, BLA, & pre-RFD, 510(k), IDE, PMA, Technical Documentation)

  • Regulatory Agency Interactions (e.g., INTERACT, PDUFA meetings, Q-Submissions)

  • Regulatory Strategy, Analysis & Development

  • Product Classification and Jurisdiction

• Manage Regulatory Affairs staff, facilitate professional development and ensure regulatory projects are completed in an accurate and timely manner.

• Lead/manage business development functions to secure new clients and projects.

• Develop project and departmental budgets and timelines, as required.

• Work directly with client companies and/or regulatory bodies without oversight.

• Provide project leadership while maintaining sole relationship with client companies.

• Lead people development projects, working alongside team managers, as required.

• Work collaboratively with other MCRA departments, including clinical, reimbursement, and quality assurance.

• Work with other department heads and executive management to guide progress and development of the regulatory department and company, as required.