Head of Regulatory Affairs - The Steely Group

We are seeking an experienced and strategic Head of Regulatory Affairs to lead regulatory efforts and ensure compliance with regulatory requirements across all stages of product development. You will be responsible for shaping and executing regulatory strategies, managing submissions, and serving as the primary interface with regulatory agencies. Reporting to the Chief Medical Officer, this is a high-impact leadership role where you will work closely with cross-functional teams to bring innovative biotech products to market.
Responsibilities:

• Regulatory Strategy Development: Develop and implement comprehensive regulatory strategies for all phases of drug and biologic development, ensuring alignment with company objectives and regulatory requirements.
• Regulatory Submissions: Lead the preparation, review, and submission of all regulatory documents, including INDs, BLAs and other regulatory filings. Ensure timely and successful submissions.
• Agency Interaction:  Serve as the primary liaison with regulatory authorities, including the FDA, and potentially other international agencies. Lead regulatory meetings, negotiations, and communications to facilitate approvals and resolve issues.
• Compliance & Risk Management:  Ensure compliance with all relevant regulations, standards, and guidelines throughout the product lifecycle. Identify potential regulatory risks and develop mitigation strategies.
• Cross-Functional Collaboration:  Partner with internal teams, including R&D, CMC, clinical development, quality, manufacturing, program management and legal to ensure regulatory requirements are integrated into development plans and operations.
• Regulatory Intelligence: Stay current on relevant changes in regulatory environments, proactively applying changes to decision-making and strategies as needed.
   

Qualifications:

• Bachelor's degree (required) or advanced degree (preferred) in life sciences (Ph.D., PharmD, or MS) or related field; a background in regulatory science, law, or healthcare is a plus.
• Minimum of 10 years of experience in regulatory affairs within the biotech or pharmaceutical industry, including at a strategic level.
• Demonstrated success in obtaining regulatory approvals (IND, BLA) for biotech products, ideally in immunology and/or rare diseases.
• In-depth knowledge of global regulatory requirements, particularly FDA, and other major health authorities.
• Excellent negotiation, communication, and interpersonal skills, with a proven ability to interact effectively with regulatory agencies and senior leadership.
• Strong leadership skills with the ability to set direction for the function and guide programs through approvals.
• Experience with regulatory submissions and compliance in a fast-paced, evolving biotech environment.