Posted: Thursday, January 4, 2018 11:36 AM
We all share one big ambition. What's yours?
Everyone who works at UCB holds the same ambition : to transform the lives of people living with severe diseases. Of course we have other associated ambitions too : including a desire to support each other in attaining all of our own personal and professional goals. That's why we ensure every UCB colleague has the tools and environment to engage effectively in the work we do. Wherever in the world we're based, and whatever role we play, we believe each of us can have an impact across our organization.
To help us meet our ambitions and provide the best solutions to patients, UCB is currently seeking a talented individual as a RegulatoryScientist based at our US Headquarters in suburban Atlanta, Georgia.
We are seeking acandidate with a strong background/experience in writingwithinUS guidelines(e.g.: Type B or Type C meeting request and briefing documents).
: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 team
:Manage quality regulatory submissions to agreed project targets
:Work flexibilty within and across regions to provide broad operational support to ensure the delivery of product team and business objectives
:Support 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.
:Lead 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.
:Liaise proactively with the functions and participate as a member of cross:functional delivery teams for complex submissions, providing regulatory advice
:Identify potential regulatory risks to the operational plan, and propose options to mitigate risks.
:Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
:Assume assigned responsibilities for routine and non:routine contact with health authorities and affiliates to support the GRL.
:Maintain awareness of competitors' activities and share potential impact these activities may have on the product development program
:Delivers project assignments supporting the business e.g. representation on functional workstreams
:Ensure that appropriate, up:to:date records are maintained for compliance
:Assist in development of regulatory standards and SOPs
:Provide input into Regulatory Strategy Plans and project budget as delegated by GRL
:Assist in due diligence activities for in:licensing opportunities
Minimum requirements : Education and Experience:
:Bachelor's degree in Science or related discipline; Masters degree preferred
:5+ years pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation
Skills and Capabilities:
:Flexibility and adaptability : Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person. Works effectively in ambiguous situations.
:Communication skills : knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
:Results focused : ability to overcome obstacles and achieve key outcomes
:Analytical : logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
:Integrity : overriding commitment to integrity and high standards in self and others
:Build effective partnerships : identifies opportunities and takes actions to build effecti
• Location: Atlanta
• Post ID: 89158782 atlanta