To strengthen our Regulatory Affairs Team, we are looking for a talented individual to fill the position of Regulatory Science Lead. This position can be based in Atlanta, GA or Raleigh, NC.
You like to work in an environment where you can:
• Prepare and deliver regulatory operational plans for assigned projects/products within a specific region.
• Provide strategic and operational regulatory input and guidance in cross-functional teams.
• Manage quality regulatory submissions to agreed project targets.
• Work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.
You will contribute by:
• Supporting the Global Regulatory Leader (GRL) for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and regional/local country regulations.
• Leading the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Liaising proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
• Identifying potential regulatory risks to the operational plan, and propose options to mitigate risks.
• Providing regulatory expertise on regulatory submissions, health authority briefing documents and response documents
• Assuming assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL.
• Maintaining awareness of competitors’ activities and share potential impact these activities may have on the product development program
• Delivering project assignments supporting the business e.g. representation on functional workstreams
• Ensuring that appropriate, up-to-date records are maintained for compliance
• Assisting in development of regulatory standards and SOPs
• Providing input into Regulatory Strategy Plans and project budget as delegated by GRL
• Assisting in due diligence activities for in-licensing opportunities