Principal Regulatory Affairs Consultant

4 tygodni temu

Warszawa, Polska Parexel Pełny etat

When our values align, there's no limit to what we can achieve.
 

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 biological products and/or vaccines. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval CMC activities. As a recognized professional in your field of expertise, you will utilize your rainmaking skills and extensive knowledge of our consulting models and methodologies to deliver exceptional consulting services to our clients. This is a unique opportunity to showcase your technical skills, specialist knowledge, and mentorship abilities.

This role can be home or office based in various European locations.

Key Responsibilities:

Develop and implement submission strategies and plans for pre- and post-approval CMC activities, including MAA/BLAs variations, renewals, market expansions, and annual reports.

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, with ability to incorporate such report data into Module 2.3/3.

Coordinate CMC submission preparation with various departments, including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and CMOs.

Write and review CMC submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.

Serve as a Project Leader, providing overall project leadership and ensuring the project's successful planning and set-up.

Act as the main client contact, maintaining accurate project reporting and delivering to meet client expectations.

Collaborate within a team environment to deliver project requirements. Prioritize workloads, both for yourself and the project team, to achieve project scope and objectives.

Deliver engaging presentations at seminars and industry group meetings. Author articles for industry publications, demonstrating expertise and showcasing Parexel's capabilities.

Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Mentor and coach more junior members of the team.

Collaborate with Account Management to prospect and leverage new business opportunities.

Effectively communicate Parexel's service offerings, demonstrating our capability to support client needs.

Experience and Skills Required:

University-level education in Life Sciences or equivalent by experience.

Extensive experience in regulatory affairs, specifically particularly related to technical/CMC/quality, within the pharmaceutical industry.

Strong understanding of CMC and post-approval regulatory requirements.

Experience in writing and SME reviewing CMC (technical) sections of regulatory documents such as registration files or variations.

Knowledge of vaccines or biological processes.

Proficient account planning and support abilities.

Networking skills to expand professional connections.

Team spirit, flexibility, accountability, and organizational skills.

Strong project leadership and management knowledge.

Strong business acumen for analysis and decision-making.

Self-confidence and control in professional engagements.

Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.

Fluent in English (written and spoken).

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