Regulatory Connect
Associate Director Regulatory Affairs
Regulatory Connect - New York, New York, United States
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Associate Director Regulatory Affairs Hybrid - Cambridge We are seeking an experienced Associate Director RA to lead global regulatory submission activities across development programs. This strategic and hands-on role will be responsible for overseeing regulatory operations & submissions, contributing to global RA strategy and ensuring timely, high-quality submissions in alignment with global health authority requirements. Key Responsibilities: Lead planning, preparation, and submission of regulatory dossiers including INDs, CTAs, NDAs, and MAAs. Provide strategic leadership and support on regulatory submissions. Manage global regulatory timelines, and ensure compliant and efficient execution of regulatory activities across development stages and product lifecycles Provide regulatory guidance to cross-functional teams including clinical, nonclinical, CMC, and commercial stakeholders. Manage responses to health authority queries (e.g., FDA, EMA, MHRA, Health Canada, TGA). Coordinate regulatory timelines, document workflows, and maintain submission compliance. Serve as the primary liaison for internal teams, external vendors, and health authorities on regulatory operational matters. Administer the Regulatory Information Management system and support document control systems. Contribute to continuous process improvement within regulatory operations. Qualifications: Bachelor’s degree required; advanced degree in a scientific field preferred. Minimum 8 years in the pharmaceutical or biotech industry, including 3+ years in regulatory affairs with direct IND/CTA/NDA/MAA experience. Strong knowledge of global regulatory requirements and electronic submission processes (e.g., eCTD). Proficiency with regulatory publishing tools and document management systems. Demonstrated project management skills and ability to thrive in a dynamic environment. Excellent communication, interpersonal, and organizational skills. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Science Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Regulatory Connect by 2x Sign in to set job alerts for “Director of Regulatory Affairs” roles.
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Associate Director Regulatory Affairs Hybrid - Cambridge We are seeking an experienced Associate Director RA to lead global regulatory submission activities across development programs. This strategic and hands-on role will be responsible for overseeing regulatory operations & submissions, contributing to global RA strategy and ensuring timely, high-quality submissions in alignment with global health authority requirements. Key Responsibilities: Lead planning, preparation, and submission of regulatory dossiers including INDs, CTAs, NDAs, and MAAs. Provide strategic leadership and support on regulatory submissions. Manage global regulatory timelines, and ensure compliant and efficient execution of regulatory activities across development stages and product lifecycles Provide regulatory guidance to cross-functional teams including clinical, nonclinical, CMC, and commercial stakeholders. Manage responses to health authority queries (e.g., FDA, EMA, MHRA, Health Canada, TGA). Coordinate regulatory timelines, document workflows, and maintain submission compliance. Serve as the primary liaison for internal teams, external vendors, and health authorities on regulatory operational matters. Administer the Regulatory Information Management system and support document control systems. Contribute to continuous process improvement within regulatory operations. Qualifications: Bachelor’s degree required; advanced degree in a scientific field preferred. Minimum 8 years in the pharmaceutical or biotech industry, including 3+ years in regulatory affairs with direct IND/CTA/NDA/MAA experience. Strong knowledge of global regulatory requirements and electronic submission processes (e.g., eCTD). Proficiency with regulatory publishing tools and document management systems. Demonstrated project management skills and ability to thrive in a dynamic environment. Excellent communication, interpersonal, and organizational skills. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Science Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Regulatory Connect by 2x Sign in to set job alerts for “Director of Regulatory Affairs” roles.
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Boston, MA $153,600.00-$241,340.00 2 weeks 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