Senior Director Regulatory Affairs - EMEA - HC Berks

Highly Competitive Director Level Salary and Package - Biotechnology - Quality & Regulatory Affairs
Ref: 92 Date Posted: Monday 07 Jan 2019
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I am delighted to be representing a pioneering Biotech client who specialise in bringing life-changing therapeutics to children and adults suffering with rare, orphan diseases.

 

My client, after successfully gaining FDA approval for a breakthrough product, are now expanding their commercial entity to the EMEA region and are in the process of establishing their European Head Office.

 

I am currently assisting them with hiring a seasoned, experienced Senior Director to take full responsibility for Regulatory Affairs across EMEA. Initially, the role will be home-based while the Head Office is set up - likely the office will be in Home Counties, UK.

 

In this newly created role, you would be fully responsible for defining and implementing global regulatory strategies; ensuring that all regulatory requirements/commitments are met with respect to regulatory submissions for INDs, IMPDs, MAAs, NDAs and other regional submissions.

 

Your key responsibilities would be;

  • Formulate & implement Regulatory strategies and plans to achieve efficient & competitive product development
  • Provide regulatory direction for the coordination, and preparation of regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines
  • Provide regulatory input into cross-functional Project Teams for product development and submission activities
  • Act as regulatory lead for the review of documentation prepared by other technical functions
  • Provide regulatory review and approve of internal documentation supporting product development activities (e.g. clinical protocols, clinical study reports, statistical analysis plans, etc.)
  • Provide regulatory input into project teams as required to provide technical guidance & to assist in problem solving/issue resolution etc.

To be successful in this role you will need the following;

  • Bachelor’s degree (scientific or clinical background desirable); advanced degree preferred
  • Minimum 8 years Regulatory Affairs experience in the pharmaceutical or biotechnology sector
  • Must have experience with managing submissions supporting marketing authorization applications (e.g. NDA, NDS and MAA) in electronic format (eCTD) submissions
  • Experience in submission writing and review experience essential
  • Experience with inhalation products would be a plus
  • Must have experience of direct interaction with Regulatory Agencies
  • Experience with preparing submission-ready PDFs
  • Experience working with the PDCO would be very beneficial, however is not essential.

 

My Client are passionate about their mission to transform the lives of their patients. They are developing novel, targeted therapies to help serve the critical unmet needs of their patients. They care deeply about their ability to improve not only the therapies received, but also improving the entire patient experience, from diagnosis and treatment to everyday living.

 

This is a fantastic opportunity to be part of the early stage establishment of the European Operation in a crucial and highly influential role.

 

If you are interested and want more information, please apply or contact Katy Wallace at kwallace@purcon.co.uk