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Abbvie
,
Maidenhead, Berkshire
Project Manager, Western Europe, Regulatory Affairs - Oncology
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 . Project Manager, Western Europe, Regulatory Affairs - Oncology Based in the Maidenhead offices with flexible working options and 15% travel. Reporting to the Therapy Area Head, Oncology. Competitive salary, Long Term Incentives, Great working environment, Bonus and comprehensive benefits package. Highlightedresponsibilities: + Implementregulatory strategies & deliverables typically for late development andmarketed products in the assigned Therapeutic Area for the WE Area (including Israel,Turkey andSwitzerland). In alignment with the overarching global regulatory strategy andregion specific requirements. + May receivedelegation to represent the Area/Affiliate regulatory requirements andinterests (RA affiliates and commercial) on the Global Regulatory Product Team(GRPT) to ensure those are met. Duly reports on activities in these teams andalerts his/her management when necessary. + Propose a Local Regulatory Strategic Tactical Plan (L-RSTP) in collaboration with the RApersonnel in the affiliates. (Area Regulatory Product Team ARPT). + Primary RAinterface with Commercial. Represent RA on the Brand Teams (provide strategicinput for registration, ensure the business needs are met by anticipating andmitigating regulatory risks while ensuring compliancewith regulations, assessprobability of success for submission, approval and launch by country andproduct). Qualifications Qualifications & experience: + Previous Pharmaceutical industry experience in Oncology, Regulatory Affairs or R&D is a must. + Demonstrable experience of working with European regulatory agencies. + Experience working effectively across cultures and in complex matrixed environment. + Strong project manager, excellent organisational skills and solution driven style. Travel Yes, 15 % 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.