Director, Regulatory Affairs, Cardiovascular / Tri-state Area / Take responsibility for global RA strategy (code USA 071220-1)

Reference: TM071220AR

Expiry Date: 28-10-2021

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Mercer County
United States

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Job Description

Director, Regulatory Affairs, Cardiovascular / Tri-state Area  / Take responsibility for global RA strategy

My client is a growing Pharmaceutical company with a strong and varied pipeline of indications in both Cardiovascular and Immunology who are looking for an experienced Director of Regulatory Affairs who will take leadership responsibility for global regulatory strategy within a development team for the Global Cardiovascular franchise.

You will have leadership responsibility for global regulatory strategy, leading in the preparation of content for regulatory strategic documentation and Regulatory Project Review, ensuring regulatory plans are aligned with global commercial and development plans.  You will help those around you to develop strategies and content for global dossiers and oversee key negotiations/meetings with the leading Health Authorities,  reviewing and approving content of responses to queries (from HA’s) for respective regions/countries.  Your team will include a number of strong performers at Manager and Snr Manager level, all with experience of submission activities for Cardiovascular product development and/or registrations

What my client is looking for in a strong candidate!

The ideal candidate will be motivated by inspiring other to perform better, reach higher and to take on challenges head on.  You will be a people leader (matrix and/or direct) and enjoy helping those around you to succeed, not only by passing on your knowledge but by giving your team the platform, the tools and the encouragement to perform. You will already have a number of submission achievements under your belt and enjoy the complexities of global submissions within the Cardiovascular world.

Why is this a great role?

I would definitely describe this organisation as one of my most dynamic clients!  They have a fantastic culture of clinical development innovation and success and although this role may start at Director level, there is no glass ceiling or limit on your own personal progression, whether that be on job title, team size, regions or area of expertise,  my client is well known for giving all regulatory staff the space and assistance to grow and take on more challenges. Also the pipeline here is exceptional and due to a number of recent acquisitions, the Cardiovascular franchise is seen by many as one of the most exciting in the industry!

Location and package!

The Global HQ is based in the Tri-state area (New Jersey) but there is good flexibility, post Covid for home working with a few days in the office. On offer is a very generous remuneration package with high basic, good bonus and excellent stock plan, with an extensive benefits scheme around pension and healthcare packages.

To Apply!

To apply, please contact Theo Moore on US toll-free 855 505 1382 or send a full CV to 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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