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Senior Regulatory Affairs Director & Group Manager

Reference Number: 2820
Location: Northeast

Our client is a major global healthcare company.  They have asked us to assist them in their search for a Senior Regulatory Affairs Director & Group Manager.

The Senior Regulatory Affairs Director (RAD) will, as required, serve as GRL/RAD for one or more programs within a designated therapeutic area providing strategic regulatory advice and leadership to their team.  As a Group Manager they will also lead, manage and as appropriate mentor and coach RADs/Senior RADs within the therapeutic area.  The Senior RAD possesses strong leadership skills, has a deep understanding of global regulatory science and overall drug/biologic development processes and strategies.  Experience and knowledge of the disease area strategy and business objectives is essential, this individual will help set clear direction for the regulatory staff reporting to them. The Senior RAD is empowered to represent the regulatory TA on high level governance bodies.

Major tasks and responsibilities will include:

  • Line manages and provides leadership to a strategic regulatory team within the TA.  Ensures the principles of performance management are used to develop staff to their full potential. Coaches/mentors staff as appropriate.
  • Provides global, strategic regulatory expertise to project teams as GRL/RAD for one or more programs within a designated therapeutic area as required.  Works with TA VP and GRLs/RADs within the team to be well informed on key regulatory issues and to provide strategic input as required in preparation for representing the TA at governance meetings.  Possesses a clear understanding of the business objectives and how regulatory strategies support those objectives.  Assures negotiations have been conducted as appropriate between the GRL/RAD, TAVP and key stakeholders as required.  Provides input as needed.
  • In conjunction with the TAVP, provides consultation and strategic support as needed for key internal governance meetings, HA meetings and other key external meetings.
  • May serve as regulatory TA representative on disease area governance bodies such as IMED and GMED leadership teams as required.  Communicates important governance body discussions and decisions with regulatory team and TAVP.
  • May manage due diligence reviews for the TA and serves on due diligence teams to provide strategic therapeutic regulatory input.
  • May assist in or lead budget management, resource planning and recruitment of staff in partnership with the Global TAVP as required. Together with the TAVP, advises on the appropriate deployment of GRL/RAD staff to Regulatory Project Teams ensuring the appropriate deployment of staff based on skills required and project prioritization. Regularly reviews such allocation to ensure optimum utilization and development of staff.
  • Contributes to or leads significant non-drug business projects as required.

We seek candidates with the following qualifications:

  • Advanced degree in science related field and/or other appropriate knowledge/experience.  Advanced degree/PhD preferred.
  • Must have previous experience in leading Major Health Authority interactions (e.g. FDA advisory committee meetings, oral explanations, scientific advice, EOP2 meetings, etc.).
  • Extensive pharmaceutical experience, including significant regulatory experience; other relevant experience in the pharmaceutical industry, for example in Research and Development or Clinical Development, might also be considered.
  • Significant experience in a strategy-setting role within Regulatory Affairs is preferred.
  • Knowledge of worldwide regulatory requirements preferred.
  • Expert knowledge of regulatory affairs within one or more therapeutic areas.
  • Significant experience managing regulatory programs in a team environment and/or previous supervisory experience.
  • Must demonstrate strategic thinking, strategic influencing, project management, leadership and excellent oral and written communication skills.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2820. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.