Job Description

Location Singapore, Central Singapore

Planning Area
QUEENSTOWN

Job Type
Permanent

Salary
$4,000 - $7,000 Per Month

Date Posted
4 hours ago

Expiry Date
14-Jun-2022
Additional Details


Job ID
184988

Job Views
1

Roles & Responsibilities Role description: The ideal candidate is a subject matter expert, technical writer, and project manager for CMC Biologics. The primary responsibility is to ensure completeness of the Quality sections of dossiers for regulatory filings and to respond to and resolve questions/comments from regulatory agencies. The position is to support the Singapore R&D site. Key responsibilities:

• Coordinate internal and external activities pertaining to the Quality section of dossiers. Provide strategic guidance to technical teams on CMC regulatory requirements.
• Review technical documents prepared by other teams and ensure accuracy, compliance, and completeness for regulatory submissions
• Prepare briefing packages and support cross-functional teams in due diligence and regulatory agency meetings, including negotiations to resolve CMC issues
• Author and drive completion of the Quality section of dossiers for clinical trial and marketing authorization applications. Ensure that final versions align with requirements and fulfill regulatory agency expectations.
• Provide responses to regulatory agency and due diligence questions, resolve issues and update dossiers in a timely manner.
• Monitor CMO/CDMO activities and provide support as a CMC subject matter expert. Review or approve technical documents (e.g. Master Batch Records, CoA, tech transfer documents) and resolve or escalate CMC/Quality issues.
• Maintain regulatory intelligence for relevant industry and agency guidance, as appropriate.

• BSc, MSc, or PhD with at least 2 years relevant experience in the biopharmaceutical / biotechnology industry.
• Proven track record of successfully authoring and delivering CMC sections for regulatory filings.
• Understanding of regulatory requirements for biological product quality. Experience with biosimilar development is a plus.
• Knowledge of upstream and downstream bioprocessing and understanding of process development, optimization, validation, scale-up, and technology transfer.
• Understanding of Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP), including standard systems (e.g. change management systems and tools).
• Project management experience with a track record in problem solving and liaison across functions.
• Proven ability to negotiate, influence, or resolve conflicting timelines / priorities.
• Proven ability to work on own initiative. Pro-active attitude with good judgement.
• Excellent organizational, planning, and time management skills. Detail oriented, but able to work efficiently with others to meet tight deadlines. Proven ability to work well under pressure.
• Excellent interpersonal, oral and written communication skills.