Non Clinical Job at USV PRIVATE LIMITED
USV PRIVATE LIMITED is hiring for a USV Deputy Manager Job: Deputy Manager – Biologics-Clinical Development and RA at its Corporate Office in Govandi East. Qualified candidates should possess relevant experience and educational qualifications.
USV Deputy Manager Job Details
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)
Job Description
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. This USV Deputy Manager Job supports accelerated market approvals through compliant clinical and regulatory execution.
Key Responsibilities
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Biosimilar Clinical Strategy & Study Management: Formulate and execute comprehensive Clinical Development Strategies for biosimilars tailored for regulated markets (e.g., USFDA, EMA).
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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).
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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.
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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.
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MOH Query Resolution: Act as the primary technical anchor for drafting, reviewing, and submitting precise, timely responses to Ministry of Health (MOH) / Regulatory Authority queries.
USV Deputy Manager Job Eligibility Criteria
Experience: 8–15 years of core experience in Clinical Development and Regulatory Affairs within the Biopharmaceutical/Biosimilars industry, with a proven track record in regulated markets. This USV Deputy Manager Job is suited to professionals with hands-on experience in these functions.
Required Skills
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Proven expertise in Clinical Development Strategies, synopsis and protocol design and review, CRO evaluation, Clinical Program Management and technical dossier authoring.
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Technical Expertise: Proficiency in CTA filings, CSR review, eCTD submission processes, and understanding of ICH-GCP guidelines.
Academic Qualifications & Certifications
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Educational Qualification: Ph.D., M.Pharm, or MD in Pharmacology.