Regulatory Affairs Expertise Opportunities

1 dzień temu


Warszawa, Mazovia, Polska Parexel Pełny etat

Unlocking the Potential of Regulatory Affairs Experts

Parexel, a leading Clinical Research Organization (CRO), is seeking an experienced Principal Regulatory Affairs Consultant (Associate Director level) to join our team. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval CMC activities.

This role offers a unique opportunity to work on challenging projects, utilize your technical skills, specialist knowledge, and mentorship abilities to deliver exceptional consulting services to our clients. As a key member of our team, you will contribute to the development and implementation of submission strategies and plans for post-approval CMC activities.

We are looking for someone with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule processes, who can provide strong support to our clients in achieving their goals. You will have the opportunity to work closely with cross-functional teams, including manufacturing, supply chain, quality control, and quality assurance departments.

About the Role:

  • Serve as a Project Leader, providing overall project leadership and ensuring successful project planning and set-up.
  • Act as the main client contact, maintaining accurate project reporting and delivering to meet client expectations.
  • Develop and implement submission strategies and plans for post-approval CMC activities.
  • Assess change controls and provide regulatory assessments of quality changes in production and quality control.
  • Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
  • Coordinate submission preparation with various departments.
  • Write and review submission content to ensure alignment with regulatory requirements.
  • Collaborate within a team environment to deliver project requirements.

Requirements:

  • University-level education in Life Sciences or equivalent by experience.
  • Extensive experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
  • Strong understanding of CMC and post-approval regulatory requirements.
  • Experience in writing CMC (technical) sections of regulatory documents.
  • Knowledge of small molecule processes.
  • Proficient account planning and support abilities.
  • Team spirit, flexibility, accountability, and organizational skills.

We Offer:

  • An estimated salary of €120,000 - €180,000 per annum, depending on experience.
  • The opportunity to work on high-profile projects with international clients.
  • A collaborative and dynamic work environment.
  • Ongoing training and professional development opportunities.
  • A competitive benefits package, including health insurance, pension scheme, and paid time off.

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