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

Parexel International Corporation

United Kingdom, Remote

We are looking for Regulatory Affairs Professionals on various levels (Senior and Principal Consultant) for a client dedicated project 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.

Job Responsibilities:Write CMC, “facility and equipment” parts and new files for WW regulatory FileManage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completionEnsure the coordination with the departments involved in the writing/review processWrite and support regulatory affairs Responses to Questions raised by Regulatory AuthoritiesMonitor that supportive data provided by other departments are compliantReport significant issuesManage the projects within all tracking toolsAssess the change controls that relate to pure facilities and equipment matters or work with GRL 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).Experience working in validation/QA/production in Biologics/Pharmaceuticals industryKnowledge of regulatory procedures / systems / guidancesKnowledge of biologic process and process equipment.Knowledge of Qualification / Validation principles.Manages own time to meet agreed short-term targetsAnalytical skills, creative and critical mind; ensures the coherence between contributions / quality of final resultsGood level of spoken and written English (other European language would be a plus)

Job posted: 2022-08-18

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