Strategic Regulatory Affairs Leader

2 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time

We are seeking a visionary Senior Regulatory Affairs Director to lead our Global Regulatory Affairs team.

The ideal candidate will have significant experience in regulatory affairs within the pharmaceutical industry and a proven track record in project management and regulatory operations.

They will be responsible for directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals.

Key responsibilities include:

  • Leading the implementation of regulatory strategies and operational activities across major global regions.
  • Providing strategic input into global regulatory plans, identifying risks and contributing to key planning documents.
  • Aligning regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams.
  • Defining and managing Health Authority interaction strategies, including preparation of briefing materials.
  • Overseeing the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans).
  • Serving as a liaison with local HAs (e.g., FDA, EMA) and leading or supporting negotiations for regional approvals.
  • Developing and implementing strategies to minimize review delays and regulatory clock stops.
  • Ensuring timely and compliant responses to HA queries and requests.
  • Contributing to departmental goal setting and leading initiatives to improve regulatory processes.
  • Ensuring adherence to internal policies, SOPs, and global regulatory requirements.

Required skills and qualifications:

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
  • Significant experience in regulatory affairs within the pharmaceutical industry.
  • Proven track record in project management and regulatory operations.
  • Experience representing the organization in cross-functional and cross-cultural settings.
  • Strong knowledge of clinical trials, drug development, and regulatory compliance.
  • Excellent problem-solving, negotiation, and communication skills.
  • Detail-oriented with the ability to manage complex regulatory projects.
  • Skilled in risk management and working with cross-functional teams.
  • Ability to navigate and influence Health Authority interactions.
  • Fluency in English (written and spoken) is essential.

Benefits:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Others:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why choose us?

We are a community of smart, passionate people who collaborate, support, and inspire each other.

Our mission is to help people with disease and their families by achieving breakthroughs that change patients' lives.

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