Publisher

7 days ago


Singapore Freyr Solutions Full time

Qualifications 2–3 years of hands‐on experience in pre‐publishing and submission publishing /Regulatory affairs Proficiency in Chinese language (reading and writing)Primary Responsibilities Work closely with submission managers to lead the production of high-quality submission assemblies eCTD/Nees/Paper format) utilizing submission‐ready documents that, adhere to internal and external electronic submission guidelines Ensure submission assemblies meet the level of technical integrity required for health authority validation tools Perform peer QC of assigned request Assist submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right‐first‐time submission assemblies Identify, assess and actively resolve or elevate where necessary any risks or issues that could impact the successful completion of regulatory submissions Secondary Responsibilities Update process related trackers on time Highlight technical issues immediately to the supervisor Keep updated on regulatory authorities’ requirements on technical/format aspects of submissions worldwide Active participation in team meeting and process relative meetings Interactions (With different internal teams/stakeholders/clients/etc.)Daily connect within team to share regular process updates Weekly connect with client to discuss publishing issues and updates Cross‐regional meetings with the client to align on Global initiatives and strategies Adhoc discussions with RPM, CMC, LOC teams to address immediate or critical concerns Seniority Level Mid‐Senior level Employment Type Contract Job Function Marketing, Public Relations, and Writing/Editing Industries Pharmaceutical Manufacturing, Retail Pharmacies, and Medical Practices #J-18808-Ljbffr


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