Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.    Job #02719 About our client Our client is a human health care company seeking innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Position Location Associate Director, Regulatory Affairs (Oncology) New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Support regulatory strategy and contribute to its outcome within the oncology area 2) Advise the management as well as recommend department operating procedures/policies to accomplish work more efficiently and with better quality control 3) Define regulatory vision and strategy to achieve a vision as well as engage and motivate the team to buy into vision and execute strategy 4) Contribute to the development of results by providing regulatory leadership 5) Handle the role of a supervisor and/or ‘subject matter expert’ with regard to regulatory issues Requirements 1) BS degree required in an associated functional discipline (Life Science, Chemistry, Toxicology or Pharmacology) 2) MD, JD, Pharm. D. or Ph. D. in Life Sciences an asset 3) 10 – 12 years of regulatory experience along with 2 – 3 years of additional related expertise (i.e. manufacturing, clinical marketing products, etc.) preferably, some broader industry experience 4) Experience in interacting with appropriate regulatory bodies 5) In-house knowledge of appropriate Code of Federal Regulations and regulatory guidance documents 6) Experience of working in a complex team environment with numerous/diverse stakeholders 7) Expertise in at least 1 area related to clinical trial management, manufacturing, non-clinical testing and marketed products as well as broad understanding and experience in the clinical development process
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