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Regulatory Affairs Specialist for CMC Compliance

1 month ago

London, Greater London, United Kingdom Parexel Full time
Job Description

Parexel Consulting is a leading provider of CMC Regulatory Affairs Services. We are seeking a highly skilled and experienced professional to join our team as a Regulatory Affairs Specialist.

In this role, you will have the opportunity to leverage your expertise in CMC, exceptional communication skills, and strong writing experience to contribute to our clients' success in the pharmaceutical industry. This position offers exposure to novel technologies and a wide range of responsibilities, from clinical trials to post-approval and maintenance.

As the Regulatory Affairs Specialist, you will collaborate closely with a multinational pharmaceutical company, ensuring the effective planning, review, and preparation of CMC components for investigational new drugs, new drug license applications, progress reports, amendments, supplemental applications, and maintenance of approved marketed products.

Key Responsibilities:
  • Technical Review and Preparation: Assist in the technical review and preparation of investigational drug applications, marketing applications, and other reports for submission to regulatory agencies.
  • Document Compliance: Ensure that documents meet established regulatory requirements in terms of content and structure.
  • Liaison and Collaboration: Serve as a liaison between various functional groups, program teams, international regulatory bodies, and business partners, proposing solutions based on your technical experience and identifying potential project timeline delays.
  • Regulatory Documentation: Maintain Regulatory CMC documentation.
  • Database Management: Manage related databases and submission schedules.
  • Submission Planning: Assist in the development of submission plans and project timelines.
  • Regulatory Agency Interaction: Prepare for and interact with regulatory agencies during drug submissions, responding to inquiries, and participating in regulatory agency inspections.
Requirements:
  • Education: University degree in a scientific field.
  • Experience: At least 5 years of relevant experience in the pharmaceutical industry or a regulatory authority.
  • CMC Expertise: Successful experience in delivering CMC sections of marketing authorizations, investigational drugs, and life cycle management of commercial products.
  • Regulatory Knowledge: Knowledge of EMA guidance, regulations, and ICH/GMP requirements.
  • Small Molecule Experience: Previous regulatory experience with small molecule.
  • EU Submissions: Experience with EU submissions via the Centralised Procedure and national procedures.
  • Extension Applications: Experience with extension applications for new strengths and/or pharmaceutical dosage forms.
  • CMC Documentation: Experience supporting the preparation of CMC documentation for IMPDs and new product EU MAAs would be advantageous.
  • Communication Skills: Ability to work independently and within project teams or committees, demonstrating accountability in achieving group goals and key project milestones.
  • Language Proficiency: Fluent in English written and spoken.

This role can be home or office-based in various European locations. The estimated salary for this position is £60,000 - £80,000 per annum, depending on experience.