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Regulatory Affairs - CMC Technical Writer (flexible location UK/EU)

United Kingdom, Remote Job ID R0000001389 Category Regulatory / Consulting Date Posted 08/17/2022
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As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

  • Communicator
  • Detail-oriented
  • Problem-solver
  • Relationship-builder
  • Results-driven
  • Strategic

About This Role

We are looking forRegulatory Affairs Professionalson various levels (Consultant and Senior Associate) for client dedicated projects within Parexel FSP Group who are CMC Technical Regulatory Writers. Technical Regulatory Writer is involved in the client’s regulatory activities related to new & existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions.

This role can be office or home based in various locations in UK and EU.

Job Responsibilities:

  • Write CMC parts and new files

  • Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion

  • Ensure the coordination with the departments involved in the writing/review process

  • Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities

  • Monitor that supportive data provided by other departments are compliant

  • Report significant issues

  • Manage the projects within all tracking tools

  • Assess the change controls that relate to pure facilities and equipment matters or work with other teams for change controls impacting both CMC and facilities.

Skills and Experience required for the role:

  • Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).

  • Knowledge of regulatory procedures / systems / guidances

  • Experience working with biologics / vaccines / small molecule

  • Knowledge of Qualification / Validation principles.

  • Manages own time to meet agreed short-term targets

  • Analytical skills, creative and critical mind; ensures the coherence between contributions / quality of final results

  • Good level of spoken and written English (other European language would be a plus)

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