Regulatory Affairs Project Manager - Oncology

AbbVie

Maidenhead, United Kingdom

The Regulatory Affairs Project Manager supports the Regulatory Affairs Manager's vision and leadership by providing patient-centric and compliant regulatory expertise. They represent the department and affiliate within AbbVie and ensure the best interests of patients, the Affiliate, and AbbVie are upheld during interactions with regulatory agencies. They contribute to the department's success by executing strategies and meeting objectives in line with business goals and culture, and actively participate in the affiliate's business initiatives.

Key Responsibilities

Supporting the business of the company, including involvement in product launches, acquisitions, and divestitures
Act as the Regulatory Lead with affiliate Commercialisation of Asset Teams and Brand Teams, providing regulatory information and developing strategies for products throughout their lifecycle
Collaborate with the Area Regulatory team to advocate for the affiliate's strategy and objectives
Liaise with Health Authorities, managing meetings and teleconferences to achieve optimal outcomes for patients and AbbVie's portfolio
Responsible for lifecycle management of products and managing Clinical Trial activities
Maintain knowledge of regulatory trends and changes, advocating for AbbVie's interests and ensuring compliance with national and EU legislation
Ensure compliance within the regulatory department, provide quality control checks, and act as a mentor for junior team members

Skills and Qualifications Required

Life Sciences Degree or equivalent experience
Varied experience within Regulatory Affairs, including commercial affiliate awareness and clinical trial knowledge
Excellent communication skills, both verbal and written
Effective influencing, tactical and presentation skills
Effective project management experience
Consultative and collaborative interpersonal style
Excellent English language skills
The ability to thrive in a changing environment and to re-prioritise workload to meet business needs

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