Head of CMC Regulatory Affairs in Pharmaceuticals

4 weeks ago


Dubai, Dubai, United Arab Emirates ClickJobs Full time

Key Responsibilities:

  • Oversee the Early Development Pharmaceuticals GRA CMC regulatory team, guiding the formulation and execution of comprehensive global CMC regulatory strategies throughout the development, commercialization, and lifecycle management phases.
  • Integrate expertise in scientific, regulatory, and business matters to ensure that regulatory submissions are of superior quality and achieve first-time approval.
  • Stay informed on current CMC and quality regulations and guidelines, establishing effective communication channels to disseminate this knowledge to relevant stakeholders, thereby promoting proactive implementation.
  • Serve as a global influencer and recognized authority within ClickJobs and among external stakeholders, including health authorities and industry peers.
  • Exhibit leadership qualities that reflect ClickJobs' values. Participate actively in the GRA-CMC Pharmaceuticals Leadership team, contributing to strategic, portfolio, human capital, and financial decisions.
  • Lead the GRA CMC Pharmaceuticals team, managing resources, developing a CMC regulatory strategy, and collaborating with global regulatory CMC stakeholders to achieve objectives.
  • Collaborate with team members to create high-quality clinical, commercialization, and lifecycle management submissions, employing proactive regulatory CMC strategies and ensuring timely submission.
  • Foster and maintain partnerships with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ, etc.) and external stakeholders (health authorities, industry associations, academia), enhancing relationship management and constructive collaboration.
  • Ensure team effectiveness in navigating a complex matrix environment within GRA, coordinating with CMC RA project leads and other GRA sub-functions to develop effective strategies and ensure project execution aligns with targets.
  • Establish and maintain a communication strategy and platform for all staff, ensuring timely dissemination of regulations, guidelines, and data through team sites or intranet. Encourage proactive thinking and a science-based approach to product development and lifecycle management activities.
  • Contribute to fostering a workplace culture and values that attract, retain, and develop top talent.
  • Ensure adherence to all applicable ClickJobs SOPs, local and international regulations, and industry best practices.
  • Represent the regulatory function in evaluating new product opportunities, both internally and externally.
  • Lead or play a significant role in relevant internal governance committees at ClickJobs.

Qualifications:

  • Advanced degree or PhD in Life Sciences, Pharmacy, or a related field.
  • A minimum of 15 years of experience in regulatory agencies or the pharmaceutical industry, with substantial leadership experience in Regulatory Sciences.
  • In-depth understanding and proven track record in navigating international regulations and policies set by major regulatory agencies.
  • Active participation in significant industry associations and joint regulator/industry initiatives.
  • Exceptional communication, collaboration, negotiation, problem-solving, and interpersonal skills, with a history of working across regulatory and industry boundaries to achieve common goals.
  • Fluency in English; additional languages are a plus.
  • Strong organizational awareness, including experience working cross-functionally and in teams.


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