Clinical Regulatory Consultant – Part Time

This biotechnology company has a nanoparticle technology platform that will allow rapid development of multiple vaccines for a variety of infectious diseases (e.g. SARS-CoV2, HIV-1, HCV, RSV, Influenza and Ebola).  They are seeking a Clinical Regulatory Consultant who can provide strategic regulatory direction for the company’s pre-clinical and clinical-stage vaccine programs. Reporting into the Chief Medical Officer, you will be responsible for developing regulatory strategies and regulatory documents for the company’s portfolio to ensure advancement of their candidates can occur successfully.  Included in this scope is the oversite of a Regulatory CMC Manager, input/review of regulatory documents, interactions with regulatory bodies and systems to ensure document compliance for both company and submission needs. This engagement will be a minimum of 10 hours a week for at least six months. This is a remote role.

RESPONSIBILITIES:

  • Participate in the development and authoring of clinical development plans with regulatory strategies embedded for multiple early-stage vaccine programs.
  • Work closely with functional leaders to effectively plan and prioritize regulatory activities in close collaboration with leads from other functional areas; inclusive of 1) creating the optimal development path for product candidates, 2) negotiating optimal development paths within internal cross-functional teams and with health authorities, 3) executing clinical-regulatory development plans on-time and while managing all identified risks.
  • Oversight/review of SARS-CoV2 preparation (IND) and lead for HIV-1 (IMPD, CTA) preparation for regulatory documents (INDs, CTAs, IB, IMPDs, etc).
  • Drive preparation (including authoring/reviewing) of FDA meeting documents, meeting requests, meeting packages, presentations, responses, etc.
  • Provide regulatory guidance to product development teams for programs in development. Ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
  • Lead cross-functional teams in preparing for health authority meetings.
  • Effectively work across Contract Research Organization, Contract Manufacturing Organization, and internal teams to align regulatory strategies and activities.
  • Develop a regulatory risk register and conduct ongoing regulatory risk assessment for programs based on company needs/gaps, regulatory precedence and product characteristics.
  • Lead the development of target product profiles and label plans.
  • Oversee regulatory submission timelines in accordance with project plans.
  • Provide regulatory expertise and policy support for good pharmaceutical development practices (GCPs, GMPs and GLPs). Ensure that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.
  • Serve as subject matter expert in global regulatory processes regulations, particularly with the US FDA and EMA and other major regulatory health bodies.
  • Participate in assessing and recommending (and later helping to establish) document management system to support both regulatory and cross functional needs.
  • Establish standard regulatory practice guidelines and identify systems/vendors for publishing requirements along with participating in process improvements for documentation practices.

 

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
  • Eight or more years of Regulatory Affairs experience for the development of pharmaceutical drugs and/or biologics.
  • Regulatory experience with biologic therapeutics required, including CBER-regulated programs. Prior experience with vaccines a plus.
  • Strong experience with clinical regulatory strategy for programs in early phase development.
  • Successful track record of filing INDs, CTAs, NDAs, BLAs, briefing packages, and various other important regulatory documents.
  • Direct experience interacting with FDA, EMA, and/or other health authorities.
  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with management.
  • Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority‐setting to meet aggressive timelines.
  • Ability to work remotely in a small, fast-paced biotech environment.
  • Excellent writing, communication, and interpretive skills
  • Able to handle multiple projects and exercise good judgment in prioritizing tasks.

NOTE:  All applicants must be authorized to work in the US.  H1B transfers cannot be accommodated.

 

Apply for this Position



Your Name*

Your Email*

Resume

Your Message

This entry was posted in . Bookmark the permalink.