Allergan
Regulatory Affairs Project Manager – Oncology
Allergan, Lincoln, Nebraska, United States, 68511
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
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LinkedIn .Job DescriptionRegulatory Affairs Project Manager – OncologyHybrid office-based in our MaidenheadAbbVie has an outstanding talent philosophy of career progression and opportunitiesExcellent compensation and benefits packageJob OverviewThe 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 ResponsibilitiesSupporting the business of the company, including involvement in product launches, acquisitions, and divestituresAct as the Regulatory Lead with affiliate Commercialisation of Asset Teams and Brand Teams, providing regulatory information and developing strategies for products throughout their lifecycleCollaborate with the Area Regulatory team to advocate for the affiliate's strategy and objectivesLiaise with Health Authorities, managing meetings and teleconferences to achieve optimal outcomes for patients and AbbVie's portfolioResponsible for lifecycle management of products and managing Clinical Trial activitiesMaintain knowledge of regulatory trends and changes, advocating for AbbVie's interests and ensuring compliance with national and EU legislationEnsure compliance within the regulatory department, provide quality control checks, and act as a mentor for junior team membersQualificationsSkills and Qualifications RequiredLife Sciences Degree or equivalent experienceVaried experience within Regulatory Affairs, including commercial affiliate awareness and clinical trial knowledgeExcellent communication skills, both verbal and writtenEffective influencing, tactical and presentation skillsEffective project management experienceConsultative and collaborative interpersonal styleExcellent English language skillsThe ability to thrive in a changing environment and to re-prioritise workload to meet business needs.Additional InformationAbbVie 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.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.html
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www.abbvie.com . Follow @abbvie on
Twitter ,
Facebook ,
Instagram ,
YouTube
and
LinkedIn .Job DescriptionRegulatory Affairs Project Manager – OncologyHybrid office-based in our MaidenheadAbbVie has an outstanding talent philosophy of career progression and opportunitiesExcellent compensation and benefits packageJob OverviewThe 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 ResponsibilitiesSupporting the business of the company, including involvement in product launches, acquisitions, and divestituresAct as the Regulatory Lead with affiliate Commercialisation of Asset Teams and Brand Teams, providing regulatory information and developing strategies for products throughout their lifecycleCollaborate with the Area Regulatory team to advocate for the affiliate's strategy and objectivesLiaise with Health Authorities, managing meetings and teleconferences to achieve optimal outcomes for patients and AbbVie's portfolioResponsible for lifecycle management of products and managing Clinical Trial activitiesMaintain knowledge of regulatory trends and changes, advocating for AbbVie's interests and ensuring compliance with national and EU legislationEnsure compliance within the regulatory department, provide quality control checks, and act as a mentor for junior team membersQualificationsSkills and Qualifications RequiredLife Sciences Degree or equivalent experienceVaried experience within Regulatory Affairs, including commercial affiliate awareness and clinical trial knowledgeExcellent communication skills, both verbal and writtenEffective influencing, tactical and presentation skillsEffective project management experienceConsultative and collaborative interpersonal styleExcellent English language skillsThe ability to thrive in a changing environment and to re-prioritise workload to meet business needs.Additional InformationAbbVie 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.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.html
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