Date: Nov 12, 2018
Prepare and deliver regulatory operational plans for assigned projects/products within Canada. Provide strategic and operational regulatory input and guidance in cross-functional teams. Manage quality regulatory submissions to agreed project targets. Work flexibly within local and international regions to provide broad operational support to ensure the delivery of product team and business objectives.
Responsibilities include, but are not limited to:
Support the Canadian Regulatory Team for the delivery of timely approvals and product information in keeping with the needs identified by the business and market and in compliance with relevant UCB procedures and local country regulations.
Lead the planning, preparation and delivery of both simple and complex submissions throughout the product's life cycle from a local perspective.
Liaise proactively with the local and global functions/colleagues 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, health authority meetings, and response documents.
Assume assigned responsibilities for routine and non-routine contact with Canadian health authorities and with global UCB colleagues.
Maintain awareness of competitors' activities and share potential impact these activities may have on the local 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 local SOPs.
Provide input into Regulatory Strategy Plans and project budget as delegated by Head of Regulatory Affairs, Canada.
Education and Experience:
Bachelor's degree in Science or related discipline
2-5 years pharmaceutical experience with knowledge of assigned Canadian regulatory procedures and legislation
Flexibility and adaptability - Decides what to do based on the situation. Changes behaviour 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 effective relationships within team and with other partners/stakeholders, both internal and external.
Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions.
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