Manager, Regulatory Affairs (1136644)

Location: Morristown, NJ

Salary: $120,000.00 USD Annually - $140,000.00 USD Annually

Description: The Manager/ Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of company’s drug development programs, policies and procedures, ensuring a compliant state of regulatory commitment. Ensures that appropriate CMC regulatory activities occur in support of both pre- and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards.

Responsibilities

Primary responsibilities of this role include the following:

• Manages all regulatory activities associated with company development projects, as assigned.
• Participates in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals for assigned projects.
• Provides guidance to multidisciplinary teams on the content, format, style and architecture of US submissions for assigned submissions.
• Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
• Manages the organization, preparation and review of new ANDAs, amendments, supplements, annual reports and other regulatory documents and correspondence, as assigned.
• Performs and manages critical analyses of data and independently develops interpretations and conclusions for discussion/consideration with regulatory management.
• Ensures the completeness and accuracy of all assigned regulatory submissions.
• Responsibility for the planning, preparation and submission of regulatory documentation according to planned timing.
  
  

Qualifications

• Advanced degree in a life science.
• Minimum of 10 years of pharmaceutical industry experience, at 8 years in Regulatory Affairs with emphasis on CMC. Must have managerial experience.
• Exhibits excellent written, verbal and negotiation skills. Must be able to effective articulate complex project related matters.
• Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
• Strong ability to prioritize, multi-task and work in a very fast paced and dynamic environment.
• Strong critical and logical thinker with ability to analyze problems.
  
  

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Contact: arawat@judge.com

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