Overview Job-IDReference25-04484 The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guideline
Responsibilities- Lead the development and maintenance of the global nonclinical and clinical regulatory strategy within the Global Regulatory Plan throughout the product lifecycle
- Ensure alignment with Clinical Development Plan and nonclinical development plans with input from SMEs and regional leads
- Provide strategic input to regulatory and development teams to inform product development
- Incorporate feedback from Health Authorities into global development strategy; follow international guidance and policies
- Develop and govern global pediatric strategy and regional pediatric content across plans and agreements
- Lead strategy for life-cycle expansion opportunities
- Contribute to Clinical and Nonclinical Development Plans with consideration of regulatory precedents
- Provide proactive regulatory expertise in design and conduct of studies and interpretation of results
- Collaborate with regional regulatory leads to assess impact of changes on pediatric plans and regulatory filings
Key requirements- Degree in health or life sciences (chemistry, molecular biology, or similar)
- 6+ years of experience with PhD; 8+ years with Masters or Bachelor's degree
- Nonclinical / Clinical Regulatory Affairs experience preferred
- Strong experience with global regulatory submissions and health authority interactions
- collaboration with cross-functional teams
- negotiation with senior leaders
- strategic thinking and advisory mindset
- global regulatory strategy
- nonclinical and clinical regulatory affairs
- health authority engagement
