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.
• Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
• Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
• Responsible for the global regulatory evaluation of CMC change controls with supervision.
• Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
• Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
• Participate in global regulatory interactions with health authorities, with supervision.
• Facilitate document review meetings and discussions.
• Develop and maintain knowledge of regulatory environment, regulations and procedures.
Skills & Requirements
• 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience
• Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
• Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
• Experience in drug development processes and 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
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.
• Life Insurance ($20,000 benefit)
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Hays is an Equal Opportunity Employer.
Drug testing may be required; please contact a recruiter for more information. #1133053