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Company Description

AbbVie'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 Description

Regulatory Affairs Project Manager – Oncology

• Hybrid office-based in our Maidenhead

• AbbVie has an outstanding talent philosophy of career progression and opportunities

• Excellent compensation and benefits package

Job Overview

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

Qualifications

Skills and Qualifications Required

• Life Sciences Degree or equivalent experience

• Varied experience within Regulatory Affairs, including commerical 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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Additional Information

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. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html