Manager Senior Mananger - Biologics-Clinical Development and Regulatory Affairs (Individual Contributor role)
Reports To: Associate Vice President
Location: Corporate Office- Govandi East
Working Days: Monday to Saturday(2nd and 4th Saturday off, 1st,3rd and 5th Saturday operational)

Role Objective
To design, drive, and execute global Clinical Development Strategies for biosimilars targeting regulated markets. This role ensures seamless clinical study management, oversees clinical CRO partnerships, and the end-to-end authoring, review, and submission of robust regulatory dossiers (eCTD). Additionally, the role is responsible for successfully resolving Ministry of Health (MOH) queries and providing strategic Regulatory Affairs (RA) support for plant-related Quality Management Systems (QMS) to ensure complete compliance and accelerated market approvals.
Key Responsibilities:
? Biosimilar Clinical Strategy & Study Management: Formulate and execute comprehensive Clinical Development Strategies for biosimilars tailored for regulated markets (e.g., USFDA, EMA).




? Clinical Trial Administration & Oversight: Lead the drafting, finalization, and submission of Clinical Trial Applications (CTA). Oversee trial data, clinical overview development, and conduct rigorous reviews of Clinical Study Reports (CSR).
? CRO Management: Selection, evaluation and finalization of CRO partner and further overview of the CRO clinical study conduct to ensure trial execution within timelines, budget, and GCP standards.
? Dossier Authoring & eCTD Submissions: Lead and execute dossier authoring with hands-on oversight of eCTD (Electronic Common Technical Document) submissions, ensuring high-quality module preparation.
? MOH Query Resolution: Act as the primary technical anchor for drafting, reviewing, and submitting exact, timely responses to Ministry of Health (MOH) / Regulatory Authority queries.
STAKEHOLDER INTERACTION
Type of Interaction: Internal
? Interaction with: R&D;, Medical Affairs, Pl

📌 Senior Manager (Govandi East)
🏢 USV
📍 Govandi East