Director, Global Regulatory Affairs - Cardiovascular, USA, New Jersey (code USA 071220-3)

Reference: RS071220AR

Expiry Date: 21-12-2021

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Mercer County
United States

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Job Description

Director, Global Regulatory Affairs - Cardiovascular, USA, New Jersey

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.

Responsibilities will include, but are not limited to, the following:

Serve as Global Regulatory Strategy Leader for late stage marketed product with multiple indications. For each indication, will:

  • Develop and create strategy for long-term planning at a cross functional level for product, consistent with the corporate and project objectives.
  • Represent regulatory in senior management discussions and present issues accordingly.
  • Interface with international affiliates on regional regulatory strategy and implementation plans.
  • Provides strategic direction to Regional Regulatory Strategy Lead in preparing teams for project related interactions with Regulatory Agency(ies).
  • May engage with Regulatory Agency(ies) on project related interactions.
  • Provide innovative solutions to challenging opportunities.
  • Responsible for the development of global regulatory strategies, in collaboration with the Global Regulatory Team and Strategic Regulatory Intelligence and Policy, which are consistent with the global Project Team goals and objectives.
  • Accountable for ensuring the appropriate implementation of the global regulatory strategy.
  • Identify issues proactively (i.e. regulatory or competitive) that will impact programs and provide strategies to address them.
  • Communicate these issues to the Global regulatory strategy leader, global regulatory sub-team and to functional management.
  • Provides insight and recommendations on health authority guidance in collaboration with the strategic liaison, policy, and regulatory intelligence group.
  • Conduct Business Development diligence efforts, if assigned.
  • Be a strategic partner and team player in the various decision-making committees within the company.
  • Engage with patient support services to maximize regulatory and development strategies.

Skills/Knowledge Required:

  • Completed Bachelor’s degree in a scientific discipline required.
  • Must have at least 10 years pharmaceutical industry experience in clinical regulatory affairs, inclusive of at least 7 years’ experience in a senior regulatory leadership role formulating strategy and driving decision-making.
  • Must be able to travel overnight for business 15% or more, depending on project needs.

This is great opportunity to join a dynamic organization. My Client has a superb culture of clinical development innovation and success with no glass ceiling on your own personal progression. They have an exceptional pipeline and due to successful acquisitions the Cardiovascular franchise is regarded 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, or if you would be interested in learning more, please contact me, Roland, via email  or via phone 855 505 1382. Alternatively, please press the red “Apply for position” button and follow the registration process.

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