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Deputy Director, Global Regulatory Affairs Strategist

Reference Number: 2665
Location: NJ

Our client is a major global healthcare company.  They have asked us to assist them in their search for a Deputy Director, Global Regulatory Affairs Strategist.

The position is responsible for the development, alignment, and implementation of regulatory strategies to ensure earliest submissions and first cycle approvals with target labels for the assigned development projects on a global basis.  Additionally, the position is in charge of assessing and aligning the probabilities for regulatory success for the assigned development projects.

Major tasks and responsibilities will include:

  • Develops Regulatory Strategy for assigned projects by designing and assessing regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory Plan).
  • Actively involved in decision making on all key development questions via an assessment on the probability of regulatory success.
  • Develops the local and global regulatory project goals from development through life cycle.
  • Represents Global Regulatory Affairs on assigned global project teams.
  • Develops submission materials for local and global submission, guides the review process, checks for accuracy, scientific consistency, compliance to local and global HA regulations, and completeness of submission.
  • Leads a global regulatory team (GRT) and coordinates worldwide regulatory input into the global development plan of assigned projects.
  • Organizes and drives preparations for meetings and teleconferences with local and global HA officials.
  • Conducts regulatory due diligence on potential in-licensing opportunities.

We seek candidates with the following qualifications:

  • Advanced technical degree (Ph.D., D.V.M., or Pharm.D.) preferably in life sciences, and 6 years in medical research activities of which 1-3 years include local/global regulatory experience in related TA area, or
  • MS degree with 8 years of medical research activities of which 3-5 years include local/global regulatory experience, or
  • BS degree with 10 years of medical research activities of which 5-10 years include local/global regulatory experience.
  • Expert knowledge of regional HA regulations, advanced knowledge of global regulations, and demonstrated interactions with local health authorities.
  • Excellent communication skills, verbal and written, and strong analytical skills are required.
  • Demonstrated leadership and project management skills, including cross-functional communication, interpersonal, and influence-management skills
  • Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and external strategic partners.

 

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 2665.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.