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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 guidelinesEnsure submission assemblies meet the level of technical integrity required for health authority validation toolsPerform peer QC of assigned requestAssist submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right‑first‑time submission assembliesIdentify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissionsSecondary Responsibilities
Update process related trackers on timeHighlight technical issues immediately to the supervisorKeep updated on regulatory authorities’ requirements on technical / format aspects of submissions worldwideActive participation in team meeting and process relative meetingsInteractions (With different internal teams / stakeholders / clients / etc.)
Daily connect within team to share regular process updatesWeekly connect with client to discuss publishing issues and updatesCross-regional meetings with the client to align on Global initiatives and strategiesAdhoc discussions with RPM, CMC, LOC teams to address immediate or critical concernsSeniority level
Mid‑Senior levelEmployment type
ContractJob function
Production and Writing / EditingIndustries : Pharmaceutical Manufacturing, Retail Pharmacies, and Medical PracticesReferrals increase your chances of interviewing at Freyr Solutions by 2x
Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia
1 month ago
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