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Senior Director, Regulatory Affairs Full-time

at Bellicum Pharmaceuticals in California (Published at 16-01-2020)

Currently we are seeking a Director of Regulatory Affairs. Reporting to the Vice President, Clinical and Medical Affairs, the Director of Regulatory Affairs will manage and execute the regulatory activities associated with Investigational New Drug files in the United States and Europe. This role requires an experienced manager that is self-directed, detailed oriented, highly motivated and has the ability to work independently. The candidate will be required work in a fast-paced and deadline driven environment, stay focused and carry out assignments in a timely and accurate manner.

Specific Job Duties

Roles and Responsibilities

  • Interpret federal regulations and assist in setting the implementation of strategies for the earliest regulatory approval.
  • Develop and implement regulatory strategies for clinical assets (both small molecule and cellular therapy)
  • Formulate or implement regulatory affairs polices and procedures to ensure compliance is maintained within the department
  • Perform review of clinical, pre-clinical and manufacturing documents for scientific content and regulatory compliance.
  • Lead interactions and negotiate with world-wide regulatory authorities to obtain the most favorable outcome supported by the evidence
  • Review and prepare responses to requests from regulatory authorities relating to products.
  • Prepare and submit applications, routine reports/renewals, including the preparation and submission of INDs, IND amendments and meetings requests with FDA and European regulatory agencies.

Skills, Minimum Education, and Experience

Qualifications

  • THIS IS AN ABSOLUTE REQUIREMENT ? proven knowledge and skills in pharmaceutical/biotech regulatory affairs
  • THIS IS AN ABSOLUTE REQUIREMENT ? experience preparing IND submissions (experience leading is desired)
  • Experience in oncology, cell or gene therapy is desired ? proven experience with CBER
  • Diverse experience with regulatory activities including interpretation of data, submission of documents to regulatory bodies.
  • Strong organizational skills that reflect the ability to perform and prioritize multiple task seamlessly with excellent attention to detail.
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
  • Demonstrated proactive approaches to problem-solving with strong decision-making capability
  • Relocation assistance will be provided to the right candidate.


Education and Experience

  • Bachelor of Science degree in related field (biology, microbiology, chemistry), Masters preferred
  • 5 or more years of relevant experience in pharma or biotech regulatory affairs
  • Proven knowledge and experience with CTD format and electronic submissions
  • Proven knowledge and experience of GLP/ GMP/GCP: FDA and ICH guidelines
  • Direct line management experience in regulatory affairs, with experience building and leading high-performance teams
  • Experience with vendor management and oversight
  • Experience with document management systems



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