Associate Director, Regulatory Affairs, Marketed Products Portfolio

Responsibilities

• Regulatory Strategy & Execution
• 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.
• Agency Engagement
• Lead interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations and responses to agency queries.
• Represent GE HealthCare PDx in regulatory meetings and industry forums.
• Cross-Functional Leadership
• Collaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies.
• Represent Regulatory Affairs on cross-functional global project teams and internal/external meetings.
• Work closely with cross-functional teams to timely execute project related activities and regulatory submissions.
• Governance & Compliance
• Foster a culture of compliance, agility, and continuous improvement.
• Ensure adherence to FDA, Health Canada, and ICH guidelines; maintain compliance and registration dossiers.
• Drive initiatives to improve regulatory efficiency and proactively manage compliance risks.
• Business Support
• Participate in due diligence for product development, acquisitions, and in-licensing opportunities; assess regulatory risks and requirements.
• Support budget planning for the Regulatory Affairs function.
• Required Qualifications & Experience
• 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
• Desired Characteristics
• Strategic thinker with strong analytical and problem-solving skills.
• Strong communication and negotiation skills.
• Proactive, solution-oriented mindset with risk management capabilities.
• Ability to work effectively in multinational and multicultural environments.
• Strong project management and organizational skills; ability to manage complex priorities.
• We will not sponsor individuals for employment visas, now or in the future, for this job opening.
• Additional Information
• GE Health

Benefits

Additional Information

Job Description Summary This role reports to the Head of Regulatory Affairs, USCAN for GE HealthCare's Pharmaceutical Diagnostics (PDx). This role drives regulatory strategy and execution for new product development and lifecycle management of marketed products. The incumbent will serve as the face of Regulatory Affairs on cross-functional teams, ensuring timely submissions, approvals, and compliance across global markets. Job Description

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