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Director, Regulatory Affairs

September 11, 2019

  

 

 

 

 

 

 

Company Name:

Cellics Therapeutics, Inc.

 

Job Location:

11588 Sorrento Valley Rd., Suite 20, San Diego, CA 92121

 

Position Title: 

Director, Regulatory Affairs

 

Position Type:

Full time

 

General Job Description:

 

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.

 

 

Responsibilities:

 

  • Develop and implement regulatory strategies for assigned programs including identifying optimal regulatory route and identifying and assessing regulatory risks.

  • Provide regulatory guidance to CMC, non-clinical, clinical teams, management, and other relevant groups on regulatory requirements

  • Perform/manage data analyses and review protocols and study reports

  • Work with functional teams on their contributions to regulatory documents and lead the preparation and submissions of regulatory filings.

  • Oversee the progress of regulatory filings and the writing of regulatory briefing documents

  • Maintain effective communications with regulatory agencies and consultants

  • Develop, maintain, and improve regulatory affairs and document management systems to support corporate activities

  • Troubleshoot and resolve regulatory management and scientific issues on projects as required in collaboration with functional teams

  • Train, and mentor regulatory affairs support personnel

  • Other tasks as needed

 

Qualifications:

 

  • Bachelors/Masters/Doctors degree in a life science discipline or equivalent, advanced degrees are preferred

  • At least 8 years of hands-on experience in Regulatory Affairs in a pharmaceutical company or biotech company that develops therapeutic products

  • Experience in biological and/or Nano-drug process development, analytical assay development, and GMP manufacturing

  • Extensive experience working with the FDA and other Regulatory Authorities, with proven successful regulatory submissions track records including IND and BLA

  • Experience in leading the team in the preparation for and the conduct of meetings with FDA and other regulatory agencies

  • Experience in the preparation and submission of regulatory documents from early stage to later stage.

  • Experience in regulatory filings of products for infectious disease preferred

  • High level knowledge of pharmaceutics and ability to apply that knowledge to complex regulatory issues

  • 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

     

     

Application Information & Contact (How to Apply)

 

Please apply by sending a resume to hr@cellics.com

Learn more about Cellics here.

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