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Publisher

Freyr SolutionsMalaysia, Malaysia

21 hours ago

Job description

1 week ago Be among the first 25 applicants

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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 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 escalate 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

Production and Writing / Editing

Industries : Pharmaceutical Manufacturing, Retail Pharmacies, and Medical Practices

Referrals 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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Publisher • Malaysia, Malaysia

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