Associate Director, Regulatory Affairs, Marketed Products Portfolio

🔥 3 hours ago

🇺🇸 United States – Remote

💵 $132k - $198k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• Develop and execute on regulatory strategies to enable timely product approvals and lifecycle management in key markets including but not limited to US and Canada. • Provide strategic regulatory advice to optimize product development (new and marketed products) and speed to market e.g. via Fast Track and Breakthrough Designations. • Assess changes to marketed products and lead post-approval submissions in key markets, including but not limited to US and Canada. • Coordinate and prepare responses to submissions related questions. • Review and contribute to submissions for products in development and marketed products, including INDs/CTAs, Clinical Study Protocols, CBEs, PAS and other documents of regulatory relevance. • Lead, co-ordinate and review the preparation of briefing documents for regulatory authority meetings, including team rehearsals, slides and minutes. • Lead interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations and responses to agency queries. • Collaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies. • Foster a culture of compliance, agility, and continuous improvement. Ensure adherence to FDA, Health Canada, and ICH guidelines; maintain compliance and registration dossiers.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred. • 5+ years of regulatory affairs experience in the pharmaceutical industry in major markets such as in US and Canada with a track record of success of submissions and approvals including new applications and post-approval changes. • Expertise in regulatory pathways from IND through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components. • Experience leading meetings with regulatory agencies such as FDA and Health Canada. • Background in sterile injectables; radiopharmaceutical experience is a strong asset

🏖️ Benefits

• medical • dental • vision • paid time off • a 401(k) plan with employee and company contribution opportunities • life insurance • disability insurance • accident insurance • tuition reimbursement