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Global Regulatory CMC Manager

Company: Hays
Location: Princeton
Posted on: November 26, 2022

Job Description:

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply. A Pharmaceutical Company is seeking a Global Regulatory CMC Manager in Princeton, NJ/Hybrid. Role Description --- Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. --- Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision. --- May be responsible for the global regulatory evaluation of CMC change controls with supervision. --- Work with CMC cross-functional teams and Regulatory Affairs teams. --- Develop and maintain knowledge of regulatory environment, regulations and procedures. Skills & Requirements --- BS/BA degree in Scientific Discipline (Masters or higher preferred) with --- 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience --- Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations) --- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations --- Experience in post-approval requirements --- Experience in developing CMC regulatory strategy --- Experience in project management --- Have a solution-oriented approach to problem solving --- Ability to plan/prioritize work of group members and guide/develop others. --- Ability to work on complex projects and within cross-functional teams with supervision --- Excellent communication skills, both written and oral --- Excellent computer skills Why Hays? You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it. Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits. --- Medical --- Dental --- Vision --- 401K --- Life Insurance ($20,000 benefit) Nervous about an upcoming interview? Unsure how to write a new resume? Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting. Hays is an Equal Opportunity Employer including disability/veteran. In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570. Drug testing may be required; please contact a recruiter for more information. #1144712

Keywords: Hays, Trenton , Global Regulatory CMC Manager, Executive , Princeton, New Jersey

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