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Senior Regulatory Affairs Manager

2 months ago

Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time
Job Summary

We are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at AbbVie. As a key member of our Regulatory Affairs department, you will be responsible for implementing regulatory strategies and deliverables for a portfolio of early/late development or marketed products for the Europe Area Regulatory Affairs (ERA).

Key Responsibilities
  • Regulatory Strategy Development: Develop and implement regulatory strategies and deliverables for assigned products, ensuring alignment with the overarching global regulatory strategy and region-specific requirements.
  • Risk Assessment and Management: Identify and assess risks associated with product development and launch, and develop mitigation strategies to ensure compliance with regulations.
  • Collaboration and Communication: Collaborate with cross-functional teams, including Commercial, Research and Development, and Quality Assurance, to ensure regulatory requirements are met and business needs are addressed.
  • Regulatory Affairs Expertise: Provide regulatory expertise and guidance to internal stakeholders, including development of regulatory strategies, submission of regulatory documents, and management of regulatory interactions with health authorities.
  • Leadership and Management: Lead and manage a team of regulatory affairs professionals, providing guidance, coaching, and development opportunities to ensure team success.
Requirements
  • Education: Bachelor's degree in a life science or related field.
  • Experience: Minimum 8 years of experience in regulatory affairs, with a strong background in pharmaceutical regulations and guidelines.
  • Skills: Strong knowledge of pharmaceutical regulations, including EU and US regulations; excellent communication and interpersonal skills; ability to work effectively in a matrixed environment.