Associate Director, Regulatory Affairs, Marketed Products Portfolio
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Job Description
Associate Director guiding regulatory strategy for GE HealthCare's pharmaceutical diagnostics. Leading submissions and compliance for marketed products in key markets such as US and Canada.
Responsibilities:
- 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.
- Represent GE HealthCare PDx in regulatory meetings and industry forums.
- 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.
- 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.
- 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.
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
- 401(k) plan with employee and company contribution opportunities
- life
- disability
- accident insurance
- tuition reimbursement
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