Regulatory Affairs - CMC Technical Writer (flexible location UK/EU)
When our values align, there's no limit to what we can achieve.
We are looking for Regulatory Affairs Professionals on 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.
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
- 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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