Director, Regulatory Affairs - Regenerative Medicine & Biologics Quality

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.

Overview

The Director, Regulatory Affairs will be a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas, as applicable. The projects may be for companies in MCRA therapeutic areas, other MCRA areas of regulatory and scientific expertise, and/or other growing therapeutic concentrations of MCRA. The Director will also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.

Responsibilities and Duties

• 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.

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.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.