Assistant Manager

Year India, India

https://www.mncjobsindia.com/company/biocon

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Job Description

Department Details
Role Summary
We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards.
Key Responsibilities
RESPONSIBILITIES:

Strong understanding of eCTD, NeeS, and ICH guidelines.
Familiarity with Regulatory systems and Publishing tools.
Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.

Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) o Manage lifecycle submissions including variations, amendments, and renewals. o Perform document-level publishing, hyperlinking, bookmarking, and validation. o Conduct quality control checks to ensure submission readiness. o Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical. o Stay updated with global regulatory guidelines (ICH, FDA, EMA). o Detail-oriented with a collaborative mindset
Educational Qualifications
Required Education Qualification: B.Sc
Required Experience: 5 - 10 years

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Job Detail

Job Id

JD3768481
Industry

Not mentioned
Total Positions

1
Job Type:

Full Time
Salary:

Not mentioned
Employment Status

Permanent
Job Location

India, India
Education

Not mentioned
Experience

Year

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