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Global Regulatory CMC Manager

Trenton, NJ 08648

Posted: 02/29/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 600099 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 60-87.07/hr **salary will be commensurate with experience 

Job Description:

PREREQUISITES BS/BA degree in Scientific Discipline (Master's or higher preferred) with 3-5+ years in the pharmaceutical industry, preferably with 2+ years CMC regulatory experience

Responsibilities will include, but are not limited to, the following:
  1. Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA and MAA regulatory filings.
  2. 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.
  3. Responsible for the global regulatory evaluation of CMC change controls with supervision.
  4. Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
  5. Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
  6. Participate in global regulatory interactions with health authorities, with supervision.
  7. Facilitate document review meetings and discussions.
  8. Develop and maintain knowledge of regulatory environment, regulations and procedures.

Skills/Knowledge Required:
  • Experience with CMC regulatory documents (IND/CTAs, 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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Trenton, NJ

Ready to take your career to the next level? Explore our job opportunities in the vibrant Trenton, New Jersey area! Nestled in the heart of the Garden State, Trenton offers a perfect blend of history, culture, and growth opportunities. From the stunning views along the Delaware River to the iconic Trenton War Memorial and historic State House, this city is rich in charm and history. Indulge in the local flavors of tomato pies and pork roll sandwiches, then immerse yourself in the thriving arts scene with visits to The Trenton City Museum at Ellarslie Mansion or catch a show at the Passage Theatre Company. With easy access to nearby Philadelphia and New York City, endless outdoor adventures in Mercer County Park, and the excitement of catching a game at CURE Insurance Arena supporting the Trenton Thunder, there's no shortage of reasons to consider Trenton for your next career move. Explore our job listings today and set your sights on a bright future in this dynamic region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.