Senior Regulatory Affairs Advisor

hace 4 semanas

Alcobendas, Madrid, España Parexel A tiempo completo

At Parexel, we believe in the power of shared values to drive success.

Parexel, a premier Clinical Research Organization (CRO), is in search of a distinguished Senior Regulatory Affairs Advisor (Associate Director level) with a strong background in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines. The successful candidate will have substantial regulatory affairs experience, adept project management capabilities, and comprehensive knowledge of post-approval CMC processes. As a recognized authority in your domain, you will leverage your expertise and extensive understanding of our consulting frameworks to provide outstanding advisory services to our clients. This position offers a unique chance to demonstrate your technical proficiency, specialized knowledge, and mentoring skills.

This role can be performed remotely or from various locations across Europe.

Key Responsibilities:

  • Lead projects by providing overall direction and ensuring successful planning and execution.
  • Serve as the primary contact for clients, ensuring accurate project tracking and fulfilling client expectations.
  • Formulate and execute submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
  • Evaluate change controls and deliver regulatory assessments of quality modifications in production and quality assurance.
  • Review reports from quality control and production teams to ensure adherence to regulatory standards.
  • Coordinate the preparation of submissions with various departments, including manufacturing, supply chain, quality control, quality assurance, and other regulatory teams.
  • Draft and review submission materials to ensure compliance with regulatory standards, particularly concerning variations and inquiries from health authorities.
  • Collaborate within a team setting to meet project requirements. Manage workloads effectively for yourself and the project team to achieve project goals.
  • Deliver compelling presentations at conferences and industry gatherings. Write articles for industry publications to showcase expertise and highlight Parexel's capabilities.
  • Identify, escalate, and mitigate risks related to regulatory processes and activities.
  • Mentor and guide junior team members.
  • Work with Account Management to identify and pursue new business opportunities.
  • Clearly communicate Parexel's service offerings, demonstrating our ability to meet client needs.

Experience and Skills Required:

  • University-level education in Life Sciences or equivalent experience.
  • Extensive background in regulatory affairs, particularly in technical/CMC/quality within the pharmaceutical sector.
  • Strong grasp of CMC and post-approval regulatory requirements.
  • Experience in drafting CMC (technical) sections of regulatory documents such as registration files or variations.
  • Knowledge of vaccines or biological processes.
  • Proficient in account planning and support.
  • Networking skills to enhance professional connections.
  • Team-oriented, adaptable, accountable, and organized.
  • Strong project leadership and management expertise.
  • Solid business acumen for analysis and decision-making.
  • Self-assured and composed in professional interactions.
  • Proficient in Word, PowerPoint, Excel, and familiarity with Veeva Vault is advantageous.
  • Fluent in English (both written and spoken).

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