Associate Director of Regulatory Affairs
About the Company:
A growing life sciences company focused on breakthrough advancements in regenerative therapies. The organization is pioneering technologies aimed at addressing critical unmet needs in transplant and cell-based treatment options. Backed by a mission-driven team, the company is committed to reshaping the future of advanced therapies through science-driven innovation.
Position Overview:
The Associate Director of Regulatory Affairs will lead regulatory strategy and operations for both preclinical and clinical-stage programs. This individual will be responsible for ensuring compliance with all relevant FDA regulations, including but not limited to CFR 1271 and guidance provided by CBER. The ideal candidate has hands-on experience in regulatory submissions, strategic interactions with the FDA, and thrives in a cross-functional, fast-paced environment.
Responsibilities
- Develop and implement regulatory strategies to support product development from early research through clinical trials and eventual market approval.
- Prepare and manage regulatory submissions, including INDs, amendments, annual reports, and meeting packages.
- Serve as the primary liaison with FDA and other regulatory authorities.
- Interpret and apply current U.S. regulatory requirements, particularly CFR 1271 and CBER-related regulations and guidance.
- Partner with cross-functional teams (e.g., R&D, Clinical, Quality, Manufacturing) to ensure regulatory compliance throughout the product lifecycle.
- Monitor changes in regulatory guidance and assess impact on the business.
- Support internal audits and inspection readiness activities.
- Manage relationships with external regulatory consultants and service providers as needed.
Desired Skills and Experience
- Bachelor’s degree in a life science or related discipline (advanced degree preferred).
- Minimum of 7–10 years of regulatory affairs experience within the biotech, pharmaceutical, or life sciences sector.
- Demonstrated experience with CFR 1271 and/or CBER-regulated products is required.
- Strong working knowledge of INDs, BLAs, and regulatory pathways for biologics or tissue-based therapies.
- Proven ability to lead regulatory strategy and author high-quality regulatory documents.
- Excellent communication, project management, and leadership skills.
- Prior experience working in a small or mid-sized biotech environment is a plus.
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