Principal Regulatory Affairs Consultant

2 dni temu

Szczecin, Polska Pharmiweb Pełny etat
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).

#LI-REMOTE

  • Senior ​Regulatory Affairs Specialist

    2 miesięcy temu

    Szczecin, Polska Coloplast Pełny etat

    Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Szczecin we have our Business Centre that works with global financial operations, orders administration, HR and IT support, Legal & Business Ethics, marketing & data analysis activities, and many others. If you have the right...

  • Labeling Engineer

    4 tygodni temu

    Szczecin, Polska 3Shape Pełny etat

    3Shape: An exciting, visionary, and international place to workJoin one of the most exciting Danish tech companies in the medical device industry and make an impact. With us you will be able to work on solutions used by thousands of dental professionals worldwide.We are currently looking for Labeling Engineer. The position is based at our Production...

  • ​Global Distributor Market Coordinator

    2 miesięcy temu

    Szczecin, Polska Coloplast Pełny etat

    Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Szczecin we are Business Centre that is responsible for global financial operations, orders administration, HR and IT support, marketing & data analysis activities, and many others. If you have the right profile and the right...

  • Site Contracts Specialist, 12 Months, 1 FTE. Must be fluent in Polish and English

    2 dni temu

    Szczecin, Polska Pharmiweb Pełny etat

    Description Senior Site Contracts Specialist Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...

  • Sr Site Contracts Specialist, English and Turkish fluent. Role based in Turkey

    4 miesięcy temu

    Szczecin, Polska Pharmiweb Pełny etat

    Description Senior Site Contracts Specialist Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...