Regulatory Compliance Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €104,000
Job Description:

This role is pivotal in overseeing the daily regulatory activities of assigned projects. The incumbent will be responsible for preparing and compiling submissions for regulatory agencies, managing regulatory submission processes and timelines, and tracking queries and commitments.

Key responsibilities include:

  • Providing ownership of projects and activities, including clinical trial applications (CTAs) and other European focused MAA pre-submission activities.
  • Contributing to and driving the regulatory content and strategy for marketing authorization submissions and pre-MAA submissions.
  • Offering regulatory guidance internally on study-team decisions.
  • Updating study/project teams of regulatory activities in the context of study team management meetings.
  • Managing and tracking queries, commitments, and submissions with reference to regulatory agencies, collaborating with subject matter experts to provide responses as necessary, and providing periodic status updates regarding unfulfilled conditions/commitments.
  • Collaborating with cross-functional study teams for planning of regulatory documents, including health authority meetings such as scientific advice, pediatric, and/or orphan designation.
  • Contributing to or leading internal meetings such as kickoff meetings, cross-functional project updates.
  • Managing/supporting internal document processes, including reviewed, finalized, signed-off, and archiving.
  • General support of global/regional regulatory submissions and strategic planning as applicable.
  • Contributing to/tracking regulatory compliance pre and post approval.
  • Other duties as assigned.
Required Skills and Qualifications:
  • BA/BS degree in biological or health-related sciences required; Master's, PhD, or PharmD preferred.
  • Minimum 3+ years of experience in Regulatory Affairs.
  • Minimum 7+ years of pharmaceutical, biotechnology, or life science industry experience.
  • Knowledgeable about EMA and European guidelines, regulations, drug development process, and industry-standard practices.
  • Possess strong written and oral communication skills.
  • Demonstrate proven interpersonal skills and experience working cross-functionally throughout the organization.
  • Detail-oriented, able to work proactively, organize, prioritize, and delegate assigned projects.
  • Experience interacting with CROs, e.g., CTAs, Clinical trial activations experience preferred.
  • Experience of EU/European health authority systems such as IRIS, CTIS desirable.
  • Proficient user of standard MS Office suite (e.g., Word, PowerPoint, Excel), experience using electronic document management systems, and document review tools desirable.

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