SkyWater Search Partners
Associate Director of Regulatory Affairs
SkyWater Search Partners, Minneapolis, Minnesota, United States, 55443
Associate Director of Regulatory Affairs
Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. Associate Director of Regulatory Affairs 2 weeks ago Be among the first 25 applicants Direct message the job poster from SkyWater Search Partners Group Director - Executive Recruiting | Connecting Candidates with Small / Mid-Market Clients across the Midwest in the Engineering, Operations, Supply… 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. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Legal and Science Industries Biotechnology Research, Medical Practices, and Research Services Referrals increase your chances of interviewing at SkyWater Search Partners by 2x Sign in to set job alerts for "Associate Director Regulatory Affairs" roles. Regulatory Affairs Manager - Electrophysiology (on-site) Associate Director, Regulatory Affairs - Cardiac Rhythm Management Arden Hills, MN $133,700.00-$254,000.00 1 month ago Senior Regulatory Affairs Specialist (on-site) Maple Grove, MN $82,600.00-$156,900.00 1 month ago Senior Regulatory Affairs Specialist - Peripheral Interventions Maple Grove, MN $82,600.00-$156,900.00 1 month ago We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. J-18808-Ljbffr
#J-18808-Ljbffr
Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. Associate Director of Regulatory Affairs 2 weeks ago Be among the first 25 applicants Direct message the job poster from SkyWater Search Partners Group Director - Executive Recruiting | Connecting Candidates with Small / Mid-Market Clients across the Midwest in the Engineering, Operations, Supply… 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. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Legal and Science Industries Biotechnology Research, Medical Practices, and Research Services Referrals increase your chances of interviewing at SkyWater Search Partners by 2x Sign in to set job alerts for "Associate Director Regulatory Affairs" roles. Regulatory Affairs Manager - Electrophysiology (on-site) Associate Director, Regulatory Affairs - Cardiac Rhythm Management Arden Hills, MN $133,700.00-$254,000.00 1 month ago Senior Regulatory Affairs Specialist (on-site) Maple Grove, MN $82,600.00-$156,900.00 1 month ago Senior Regulatory Affairs Specialist - Peripheral Interventions Maple Grove, MN $82,600.00-$156,900.00 1 month ago We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. J-18808-Ljbffr
#J-18808-Ljbffr