Biological E. Limited Hiring for Regulatory Affairs Department

Biological E Limited Job Opportunity for Regulatory Affairs | Hyderabad

Company Overview

Biological E Limited is a globally recognized vaccine and biopharmaceutical company with a strong presence in regulated and emerging markets. With a legacy of innovation and quality, Biological E offers excellent career opportunities for regulatory professionals in vaccines and biotechnology.

 Position Details

• Role / Designation: Senior Executive / Executive – CTD Specialist (ROW Markets)

• Department: Regulatory Affairs

• Job Location: Genome Valley, Shamirpet, Hyderabad

• Preferred Industry: Vaccines / Biotech

 Eligibility Criteria

• Qualification: M.Pharmacy / M.Sc

• Experience: 5 – 9 Years (Relevant Regulatory Affairs experience)

Key Responsibilities

• Regulatory submissions for ROW (Rest of World) markets

• Handling and expansion of product portfolios & market registrations

• Preparation, review, and submission of applications to RCGM / IBSC

• Expertise in Indian NRA submissions (CT-10, CT-16, CT-18, CT-40, Export NOC, etc.)

• Hands-on experience with Indian NRA portals: SUGAM, IBKP, NSWS, ODLS/ONDLS

• Authoring & compiling CTD / ACTD / eCTD dossiers for:

  • India

  • Emerging Markets

  • Regulated Markets

  • WHO Vaccine Prequalification

• Preparation of Pre-IND, Clinical Trial, Scientific & Briefing Packages

• Handling post-approval changes, variations & comparability packages

• Responses to queries from India, EM, WHO & Regulated Authorities

• Participation in Health Authority & WHO audits/inspections

• Cross-functional coordination with QA, QC, Production, Warehouse, Marketing & Distribution

• Review of artworks, labels, package inserts & pack profiles

• Use of regulatory systems/tools: Veeva Vault, TrackWise, DMS, Lorenz/PharmaReady, MS Office, PDF tools

 How to Apply

Interested candidates with relevant experience may share their updated CV to:

 HR.Intern4@biologicale.com
 Email Subject: Applying for “Regulatory Affairs”

Why Join Biological E?

•  Exposure to global regulatory submissions

•  Work with a leading vaccine & biotech organization

•  Strong career growth in regulated markets & WHO PQ

•  Innovation-driven and compliance-focused environment