Job description

Regulatory Affairs Director

Conshohocken, Pennsylvania, Rockville, Maryland, Remote

Regulatory Affairs Director 
US - Conshohocken (Pennsylvania) or Rockville (Maryland)
 
Immunocore is an innovative and dynamic biotechnology company developing a unique platform of T Cell antigen receptor-based therapeutics, called ImmTAXs, as a novel class of treatments for cancer, infectious and autoimmune diseases.

Immunocore has a well- established pipeline of wholly owned programmes, of world leading science and strong IP position, which has led to discovery collaborations with Genentech, GlaxoSmithKline, Medimmune as well as a co-discovery & co-development partnership with Lilly, and recent investment from the Bill & Melinda Gates Foundation.

The Regulatory Affairs Director is responsible for assigned projects and all of the regulatory affairs activities by providing expertise to Immunocore’s development programs to include: regulatory strategy development, development, submission, and maintenance of INDs as well as BLAs/sBLAs, agency liaison, and regulatory intelligence.  The role will also involve interacting with our global sites, both in-house and outsourced.  Establishing a successful relationship with the FDA, along with being responsible for overseeing submissions to the EMA, MHRA, and other local health authorities providing an opportunity to develop worldwide regulatory experience.

A key responsibility for this position is promotional material review and submission for late stage projects and post–approval products.

The ideal candidate will possess excellent leadership skills, have experience in review of promotional materials for approved oncology products, experience and understanding of the development of anti-infectives (specifically anti-viral agents), an understanding of biologics, and the preparation and submission of global regulatory fillings.  This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to lead the regulatory strategy through effective collaboration and be able to deliver and work well under pressure as this will be a high-profile role.

This is a temporary position, anticipated to be for 6-12 months.

EXPERIENCE & KNOWELEDGE

 Essential

  • Solid track record in drug development and leadership within a dynamic organization and cross-functional project team(s)
  • Solid scientific background with experience in developing sound regulatory strategy
  • Strong understanding of global regulatory requirements to be able to form tactical regulatory strategies
  • Solid track record in regulatory leadership for preparation, review and approval of promotional material.  Experience in preparing electronic submission of promotional material to FDA.
  • Excellent knowledge of US regulatory requirements and extensive experience with submissions gained within drug development.  Global experience desirable.  Experience in working cross functionally and globally within Regulatory Affairs
  • Experience in supporting global clinical studies
  • Experience in managing, preparing, reviewing, and submitting INDs/CTAs, marketing applications, and promotional materials
  • Experience in preparing, and conducting Health Authority Meetings (FDA required; ex-US desireable).  Ability to develop and maintain a constructive liaison relationship with FDA and other global Health Authorities.
  • Demonstrate ability to be agile to accommodate changing priorities
  • Must have proven leadership, excellent communication and interpersonal skills

Preferred Experience & Knowledge

  • Experience in early-stage development of anti-infectives (anti-virals) ensuring they advance seamlessly through each stage of development towards approval
  • Experience in managing, preparing, reviewing, and submitting INDs/CTAs, marketing applications, and promotional materials. Submission of at least 1 NME BLA/NDA is highly desirable
  • Experience in preparing, and conducting Health Authority Meetings (FDA required). Ability to develop and maintain a constructive liaison relationship with FDA and other global Health Authorities

EDUCATION & QUALIFICATIONS

BS with 8+ years’ experience

Advanced degree preferred (M.S., PharmD, Ph.D., or M.D.)

 

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position. 

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