Regulatory Affairs Manager – UK and Ireland

Job title:

Regulatory Affairs Manager – UK and Ireland

Company

AbbVie

Job description

Company DescriptionAbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.Job DescriptionRegulatory Affairs ManagerJoin us at Abbvie, in our Maidenhead office as a Regulatory Affairs Manager. We offer a hybrid working model, excellent career progression opportunities, and a comprehensive benefits package. This is an opportunity to be part of our UK regulatory leadership team and make a significant impact on our business.About the Role:As a Regulatory Affairs Manager, you will play a pivotal role in leading a team of Project Managers and Specialists, obtaining, and maintaining marketing approvals for our products in the UK. Implementing the regulatory strategy for the UK. Ensuring full regulatory and company compliance, and provide regulatory expertise to support clinical research, product launches, and business development.Your key responsibilities include:

  • Leading a team of Project Managers and Regulatory Affairs Specialists focused on the UK market.
  • Managing all regulatory activities relating to licensing, regulatory changes, and submissions to MHRA.
  • Contributing to a Brand Team representing Regulatory Affairs.
  • Reviewing ABPI code including materials assessed, examined, or certified by a non-pharma final signatory.
  • Leading continuous and process improvement projects.

QualificationsAbout You:

  • Hold a university degree in Pharmacy, Pharmacology, Biology or related disciplines.
  • Have experience in a regulatory affairs position with a strong understanding of the UK market.
  • Experience in line management or coaching is preferred.
  • Have strong communication and coordination skills, and proficiency in communicating strategic and tactical issues to management.
  • Demonstrate proven interpersonal skills and experience in working cross-functionally in a matrix organization.
  • You should have the ability to influence upwards and get work done through people, irrespective of reporting relationships.

We look forward to welcoming you to our team!Additional InformationAbbVie 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.

Expected salary

Location

Ireland – Maidenhead, Berkshire

Job date

Tue, 25 Jun 2024 00:42:01 GMT

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