Senior Regulatory Affairs Specialist

hace 2 semanas


Alcobendas, Madrid, España Parexel A tiempo completo

Unlock Your Expertise in Regulatory Affairs with Parexel

Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. As a recognized professional in your field of expertise, you will leverage your technical skills and knowledge to deliver exceptional consulting services to our clients.

Key Responsibilities:

  • Provide project leadership, ensuring successful 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 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.
  • Deliver engaging presentations and author articles for industry publications.
  • Identify and mitigate risks associated with regulatory procedures.
  • Mentor and coach junior team members.
  • Collaborate with Account Management to prospect new business opportunities.

Experience and Skills Required:

  • University-level education in Life Sciences or equivalent by experience.
  • Extensive experience in regulatory affairs, particularly related to CMC and quality.
  • Strong understanding of CMC and post-approval regulatory requirements.
  • Experience in writing CMC sections of regulatory documents.
  • Knowledge of small molecule processes.
  • Proficient account planning and support abilities.
  • Networking skills.
  • Team spirit, flexibility, accountability, and organizational skills.
  • Strong project leadership and management knowledge.
  • Business acumen for analysis and decision-making.


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