Senior Director, Regulatory Affairs Oncology 1009483
Job Scope & Purpose:
Our long-term, established oncology-focused client is seeking an experienced drug Regulatory Affairs professional to join their collaborative team environment. Sr. Director, Regulatory will manage and provide strategic leadership for regulatory strategy, agency interactions, and submissions for US FDA, EMA, and other key market Health Authorities as applicable and ensure these activities are consistent with the overall global strategy and activities. An integral part of this role is to foster strong relationships and advocacy with FDA as well as other international regulatory authorities, as required. This leadership role will entail oversight of vendors for the preparation of the regulatory submissions and interaction with key members of the Project Teams and agencies/health authorities. This individual will function as a key team member of the team, influencing the development strategy and to defend the regulatory position with health authorities.
Primary Job Responsibilities:
Primary Job Requirements:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at email@example.com or 844-463-6178.