Regulatory Affairs Global/US Liaison “Star Role” in Cardiovascular - Tri-state area (code USA 071220)

Reference: TM071220R

Expiry Date: 21-03-2021

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Mercer County
United States

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Job Description

Regulatory Affairs Global/US Liaison “Star Role” in Cardiovascular - Tri-state area

We have a senior level regulatory affairs strategic leadership role focused on Cardiovascular as a therapy area for a strong and innovative Pharmaceutical company offering a “star role” with access to exciting projects, in varied stages of development for a strong and innovative Cardiovascular portfolio. These roles will are seen as key positions for the franchise, so are highly visible within the organisation, with great support available from a Snr Director with a significant number of submission achievements in the Cardio space.

The Cardiovascular portfolio can easily be described as being diverse, broad-based and varied, and has approx. 20 indications still in development with a global blockbuster ($8biillion in sales) as part of the marketed products portfolio.

I would definitely describe this organisation as one of my most dynamic clients!  They have a fantastic culture of clinical development innovation  and due to the continued growth and expansion of their pipeline, they are looking for experienced Regulatory Snr managers take leadership and responsibility for US and Global submissions based from the from Global HQ in New Jersey. There will be options available to work on a least 2 major projects and there are indications that are in early as well as late development.

Role:

You will be providing leadership for global and regional regulatory strategy within a development team within the Cardiovascular franchise, serving as the regulatory lead for your indications, leading (or co-leading) on marketing application submission teams for indications that are at the regulatory filing stage and helping to develop strategy and content for global dossiers as well as support the preparation and participle in and/or/ lead key HA interactions.

Required:

  • Scientific background with a minimum of a Bachelor’s degree.
  • Understanding of scientific content and complexities and good knowledge of Cardiovascular or Respiratory development is desired.
  • Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.
  • Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.

 In return, my client is offering really interesting career leadership pathways and great opportunities for further challenges.  The remuneration package is exceptional and this role comes with a bonus and good / lucrative stock plan.

To Apply!

To apply, please contact Theo Moore on US toll-free 855 505 1382 or send a full CV to Theo@AdvTalent.com for more information and/or to discuss this role further. Alternatively, please press the red “Apply for position” button and follow the registration process.

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