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Abbvie
,
Maidenhead, Berkshire
Associate Director, Regulatory Affairs, Immunology, WEC
Overview
Job Description
About AbbVie AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie at on Twitter, Facebook at or LinkedIn at . AssociateDirector, Western Europe, Regulatory Affairs - Immunology Based in the Maidenhead offices with approx. 10% travel Reporting to the Therapy Area Head, Immunology Highly competitive salary, LTI's, Car Allowance, great working environment, Bonus and comprehensive benefits package. The company: AbbVie is an ambitious health business where people and quality of life come first. The experience of illness is personal, so we care about the things that matter to patients. As market leader, we team with partners to co-design health solutions around our innovative medicines for complex diseases, which improve standards of care. Helping people to be fit for work and family life is how we make a remarkable impact to the lives of men, women and children. The role: This very exciting opportunity be at the forefront of Immunology at AbbVie, Defining and implementing Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds (early development, late development, marketed) for the Western Europe region (including Israel, Turkey and Switzerland). Highlightedresponsibilities: + Define and implement regulatory strategies, riskassessment & deliverables for early, late development compounds andmarketed products in the Immunology Therapeutic Area for the Western EuropeArea (including Israel, Turkeyand Switzerland). + Identify and advocate region's requirements in theoverarching global regulatory strategy; develop risk assessment of theproject(s) and make sure it is taken into account at the Global Regulatory ProjectTeam (GRPT). + Represent the Area/Affiliate regulatory requirements andinterests (RA affiliates and commercial) on the GRPT to ensure those are met.Duly reports on activities in these teams and alerts Therapeutic Area Head whennecessary. + Develop a Regulatory Strategic Tactical Plan (RSTP) i ncollaboration with the RA personnel in the affiliates. + Coaches and mentors regulatory professionals. + Transfers knowledge to the Therapeutic Area. Qualifications Qualifications & experience: + Extensive pharmaceutical industry experience in Regulatory Affairs or R&D + Previous Immunology &/or specialist product experience preferred + Experience of working in European regulatory environment + Experience working effectively across cultures and in complex matrixed environment + Strong leadership presence and solution driven style Travel Yes, 10 % of the Time Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.