Director, Regulatory Affairs
September 11, 2019
Cellics Therapeutics, Inc.
11588 Sorrento Valley Rd., Suite 20, San Diego, CA 92121
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.