Grifols

Director, R&D Global Regulatory Strategy Lead

Grifols

full-time

Posted on:

Location Type: Hybrid

Location: Clayton • North Carolina • United States

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Salary

💰 $180,000 - $250,000 per year

Job Level

Senior

About the role

  • Develops and oversees worldwide regulatory strategies for projects and initiatives affecting new products or new indication development.
  • Responsible for clinical aspects of LCM initiatives.
  • Leads the regulatory team assigned to the respective project to ensure alignment and integration of all aspects of development and seamless execution of strategy and submissions.
  • Leads interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly impact the business.
  • Serves as a resource to other departments inside and outside of R&D on regulatory-related product development issues.
  • Guides, directs, and leads staff, and develops department goals in accordance with business priorities.

Requirements

  • Requires Ph.D., Pharm. D., M.D. or equivalent
  • 8 years direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry.
  • Excellent oral and written communication skills.
  • Strong critical thinking and problem solving skills.
  • Excellent and demonstrated project management skills.
  • Ability to negotiate and influence regulatory officials.
  • Ability to work cross-functionally to effectively implement and oversee R&D regulatory programs.
  • Ability to evaluate complex issues, develop a plan, and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives.
  • Ability to work within a global team framework and multi-cultural environment.
Benefits
  • Medical
  • Dental
  • Vision
  • PTO
  • 9 paid Holidays per year
  • up to 5% 401(K) match
  • tuition reimbursement

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory strategiesclinical aspectsproject managementnegotiationcompliance evaluationproduct developmentR&D regulatory programs
Soft skills
oral communicationwritten communicationcritical thinkingproblem solvinginfluencecross-functional collaborationgoal development
Certifications
Ph.D.Pharm. D.M.D.