Regulatory Affairs Specialist

7 days ago

Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €90,000 - €120,000
Job Title

The Manager, Regulatory Affairs Global CMC is responsible for ensuring global regulatory compliance by aligning with external requirements and internal quality procedures. The role involves demonstrating regulatory expertise, sharp decision-making, and collaboration to develop and execute regulatory strategies, manage submissions, and review policies.

Key Responsibilities:

  • Ensure global regulatory compliance by aligning with external requirements and internal quality procedures.
  • Demonstrate regulatory expertise, sharp decision-making, and collaboration to develop and execute regulatory strategies, manage submissions, and review policies.
  • Create and execute robust regulatory strategies to mitigate risks and address technical and scientific challenges.
  • Prepare and deliver high-quality CMC submissions to global regulatory agencies, managing timelines and ensuring alignment with regulatory commitments.
  • Serve as a CMC representative, managing project activities, assessing risks, and developing global regulatory strategies.
  • Support post-approval changes, new registrations, renewals, and responses to agency queries while performing quality reviews of CMC submissions.
  • Build strong relationships with internal and external partners, including regulatory authorities, to drive regulatory success.
  • Mentor colleagues, provide technical guidance, and share expertise to advance team capabilities.
  • Participate in pharmaceutical industry conferences and represent the company on advisory committees when required.
  • Manage and contribute to CMC-related projects, initiatives, and training activities, while adhering to the company's values and principles of integrity.

About Your Skills & Experience:

  • A degree in Natural Sciences with 6 years of experience in the pharmaceutical industry, with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 3 years of pharmaceutical regulatory experience is required.
  • At least 2+ years of hands-on CMC authoring experience, including initial registrations or post-approval variations, is preferred.
  • A solid understanding of cGMPs, development, and commercial activities to assess the technical and regulatory merits of CMC data is necessary.
  • Knowledge of global regulatory requirements, submission processes, and interactions with regulatory authorities is essential.
  • Proven ability to interpret and apply global and regional CMC guidelines to shape strategic regulatory directions is required.
  • Awareness of emerging scientific and manufacturing technologies and their application in regulatory strategies is beneficial.
Required Skills and Qualifications
  • Natural Sciences degree
  • 6 years of pharmaceutical experience
  • 3 years of pharmaceutical regulatory experience
  • 2+ years of CMC authoring experience
  • cGMPs knowledge
  • Global regulatory requirements knowledge
  • CMC guidelines interpretation skills
Benefits

This role offers the opportunity to work in a dynamic and challenging environment, with a competitive salary and benefits package.

Others

Please note that this job description may be subject to change, and the company reserves the right to modify or withdraw it at any time.

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