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Regulatory Affairs CMC

  • Ref: 297598
  • Type: Long Term Contract
  • Location: Hoboken, NJ
  • Industry: Pharmaceuticals
  • Job Level: Experienced Non-Manager
  • Pay: $150,000 - $190,000

Opportunity Description

CMC (Regulatory) Consultant

Your Role

The CMC (Chemistry, Manufacturing and Controls) Consultant will support the implementation of Company local and global Company strategies.  He/she will provide support for cross-functional collaborations to integrate CMC programs for Company investigational products. The incumbent is also responsible for leading aspects of CMC regulatory submissions and will serve as an internal representative/contact for CMC regulatory activities.

  • Must be able to work on-site full-time. 

 

Job Duties

  • Contributes to development of programs/processes that support development of Investigational or New Drug Applications. 
  • Collaborates with CMC counterparts overseas and other departments to execute CMC submission activities, including meeting requests and briefing documents for FDA meetings, and INDs/NDAs submitted to regulatory agencies. 
  • Executes the timely preparation, review and submission of high-quality CMC content for Company submissions of all types and their amendments and supplements as assigned.
  • Lends functional expertise and supports CMC related discussions, negotiations and responses with FDA and internal stakeholders such as Production Technology, Quality Operations, Commercial manufacturing, Supply chain, etc.     
  • Interfaces with technical, and regulatory in Japan, as required, on CMC related projects and issues.
  • Support global CMC process development and improvement as required.
  • Provides ongoing lifecycle support for marketed commercial products. 
  • Evaluates and contributes to the outsourcing of manufacturing efforts and change controls, the assessment of regulatory impacts, and provides support for their implementation.
  • Represents Regulatory Affairs CMC function, as required, at various cross-functional team meetings and working group meetings, providing solutions when possible to the project teams on CMC related problems. Escalates more complex issues to the Sr. Director, CMC. 
  • Maintains up-to-date knowledge of relevant FDA and ICH requirements relating to CMC activities. 
  • Advises and updates teams on the impact of new legislation, regulations and guidance on development plans and registration strategy as it relates to CMC sections for INDs/NDAs.

Education

  • Education: Minimum B.S. in Pharmacy, Chemistry, Chemical Engineering or related field  
  • Advanced degree (M.S. or Ph.D.) is preferred 

Experience & Skills Required

  • No remote workers.
  • Professional Experience: Minimum 5-8 years of experience in CMC activities including submissions to regulatory agencies, interaction with regulatory authorities, and CMC module development and review experience  
  • Knowledge and Skills: Strong knowledge of pharmaceutical development of drug substance and drug product
  • Knowledge of FDA and ICH regulations/guidance as it applies to CMC/Quality
  • Project management abilities 
  • Experience working in a multi-cultural, multi-lingual environment; Japanese company experience is preferred but not required
  • Demonstrated ability to contribute successfully in a multi-disciplinary team environment/matrix organization 
  • Working knowledge of DP and API GMP is preferred
  • Competency in MS Office, MS Project
  • Willingness to travel domestically up to 10%

Other Information

INDNJ #ZR3