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Director of Regulatory Affairs

Company Name: Cellics Therapeutics, Inc.
Location: San Diego, CA
Job Type: Full-time
Contact Name: Lili Xie
Phone: 858-412-6148
Fax: 858-210-6111
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary:

Job Description (up to 200 words):

 

Cellics Therapeutics Inc. is a near clinical stage biotech company located in San Diego that focuses on the development and commercialization of novel anti-virulence nanotherapeutics. Cellics has a rich pipeline in infectious diseases, rare and ultra-rare diseases, anti-venom, and vaccines. The company is seeking to recruit a Director of Regulatory Affairs to join our dynamic and collaborative team.

 

Position Summary:

The Director of Regulatory Affairs is responsible for developing practical regulatory plans and strategies for therapeutic products, communicating with regulatory agencies, ensuring timely preparation, review, and submission of documents to regulatory agencies, and maintaining compliance with applicable regulatory requirements to achieve corporate goals effectively.


Essential Duties and Responsibilities:

 

  • Develop and implement regulatory strategies including identifying optimal regulatory route and identifying and assessing regulatory risks;
  • Provide regulatory guidance to other functional teams;
  • Review protocols and study reports;
  • Work with functional teams on their contributions to regulatory documents;
  • Lead the preparation and submission of regulatory filings;
  • Oversee the writing of regulatory briefing documents and the progress of regulatory filings;
  • Maintain effective communications with regulatory agencies;
  • Coordinating with outside regulatory consultants and vendors;
  • Develop, maintain, and improve document management systems to support regulatory activities;
  • Train and mentor regulatory affairs support personnel.

Job Requirements (up to 200 words):

 

Qualifications:

 

  • Bachelors/Masters/Doctors degree in a life science discipline or equivalent, advanced degrees are preferred
  • 8+ years of Hands-on experience in Regulatory Affairs in pharmaceutical or biotech companies for therapeutic products
  • Extensive experience working with regulatory agencies, with proven successful regulatory submission track record including IND, NDA, and BLA submissions
  • Experience in leading the team in the preparation for and conduct of meetings with regulatory agencies
  • Experience in the preparation and submission of regulatory documents from early stage to later stage.
  • High level knowledge of pharmaceutics and ability to apply that knowledge to complex regulatory issues
  • Experience in process development, analytical assay development, and GMP manufacturing is a plus
  • Strong interpersonal skills and ability to communicate effectively and maintain good relationships even when dealing with demanding, complex or controversial issues
  • Excellent oral and written communication skills
  • Strong strategic, analytical, and negotiation abilities

 

To apply, please submit your CV to This email address is being protected from spambots. You need JavaScript enabled to view it.