Global Regulatory Affairs Director

3 days ago

Cork, Cork, Ireland beBeeDirector Full time €100,000 - €120,000

Job Title: Global Regulatory Affairs Director

This position plays a crucial role in leading the global labeling strategy for pharmaceuticals, ensuring timely delivery of core labeling documents and collaboration with cross-functional teams.

Key Responsibilities:
  • Develop and implement a comprehensive global labeling strategy to facilitate simultaneous global submissions.
  • Implement initiatives related to global labeling strategy, such as accelerating reach and scale.
  • Represent assigned products in drug development teams and affiliate regulatory business partners.
  • Lead core labeling development and maintenance, including data sheets, device labeling, and clinical trial instructions.
  • Communicate initial and revised core labeling to global affiliates and provide support and consultation.
  • Optimize core labeling exception process, manage requests, and facilitate approval from leadership.
  • Serve as subject matter expert for core labeling and drive continuous improvement in labeling processes.

The ideal candidate will have a Bachelor's degree in a scientific or health sciences discipline, industry-related experience in regulatory affairs, and demonstrated knowledge of the drug development process.

They will also possess strong communication skills, ability to lead and influence cross-functionally, and attention to detail and organizational skills.

Minimum Qualification Requirements:
  • Bachelor's degree in a scientific or health sciences discipline (or equivalent experience)
  • Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years
  • Demonstrated knowledge of the drug development process and regulatory/business strategies
  • Demonstrated ability to assess and manage risk in a highly regulatory environment
  • Demonstrated ability to lead, influence and partner cross-functionally
  • Demonstrated strong communication skills: writing, presenting, listening
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
  • Demonstrated attention to detail and organizational skills
  • Ability to learn and use new software/technology
  • Ability to manage multiple tasks simultaneously

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