Regulatory Affairs Specialist

4 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €120,000 - €168,000
Global Regulatory Affairs Leader

This is a senior role within our organization that oversees the development and execution of global regulatory strategies. The Global Regulatory Affairs Leader will be responsible for creating high-quality regulatory strategies, managing health authority interactions, and ensuring strategy execution.

The ideal candidate will have significant experience in regulatory and pharmaceutical development, with expertise in regulatory strategy, scientific data analysis, and health authority guidance. They will also possess excellent communication, influencing, and problem-solving skills.

As a leader, this individual will be responsible for leading regulatory teams, providing feedback and coaching, and supporting the growth and development of team members. They will also be responsible for managing regulatory submissions, portfolio transformation activities, and business and operational excellence tasks.

This is an exciting opportunity to join our team and contribute to the development and execution of global regulatory strategies.

Required Skills and Qualifications:
  • Bachelor's or Master's degree in a science-based field; advanced degrees preferred.
  • Fluent in English; additional languages are a plus.
  • Significant experience in regulatory and pharmaceutical development (Phases I-IV).
  • Expertise in regulatory strategy, scientific data analysis, and health authority guidance.
  • Significant experience with major submissions.
  • Knowledge of post-marketing strategies and commercial awareness.
  • Proven regulatory operations and compliance skills.
  • Strong leadership and matrix management abilities.
  • Excellent communication, influencing, and problem-solving skills.
Benefits:

We offer a competitive salary and benefits package, including a comprehensive health insurance plan, 401(k) matching, and generous paid time off. We also provide opportunities for professional growth and development, including training programs and mentorship opportunities.

Others:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. If you are passionate about contributing to the development and execution of global regulatory strategies, we encourage you to apply for this exciting opportunity.

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