Regulatory Affairs Specialist

1 month ago


Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time

Job Overview

The Regulatory Affairs Project Manager plays a crucial role in supporting the Regulatory Affairs Manager's vision and leadership by providing patient-centric and compliant regulatory expertise. They represent the department and affiliate within AbbVie, ensuring the best interests of patients, the Affiliate, and AbbVie are upheld during interactions with regulatory agencies.

Key Responsibilities

  • Supporting the business of the company, including involvement in product launches, acquisitions, and divestitures
  • Acting as the Regulatory Lead with affiliate Commercialisation of Asset Teams and Brand Teams, providing regulatory information and developing strategies for products throughout their lifecycle
  • Collaborating with the Area Regulatory team to advocate for the affiliate's strategy and objectives
  • Liaising 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
  • Maintaining knowledge of regulatory trends and changes, advocating for AbbVie's interests and ensuring compliance with national and EU legislation
  • Ensuring compliance within the regulatory department, providing quality control checks, and acting as a mentor for junior team members

Qualifications

  • 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

About AbbVie

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.



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