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Parexel Regulatory Affairs Jobs 2025 – Walk-In Drive

Published on

Parexel

B.Pharm, M.Pharm, Msc, BSc, Lifesciences or relevant Degrees

Bengaluru

2 - 10 Years

Verified Job

Walk In Interview
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Parexel has announced a major Walk-In Drive for Regulatory Affairs jobs in Bengaluru for experienced candidates across Biologics, Small Molecules, CMC, and Labelling. This hiring event on 20th December 2025 is a prime opportunity for RA professionals seeking growth in a top global CRO known for strong scientific, clinical, and regulatory expertise.

If you have experience in Lifecycle Management (LCM), CMC submissions, global labeling, vaccines, monoclonal antibodies, CCDS/USPI, and international regulatory procedures, this Parexel walk-in is tailored for you.


📅 Parexel Walk-In Drive Details

  • Date: 20 December 2025
  • Time: From 10 AM onwards
  • Location: Parexel Bengaluru Office
  • Type: Walk-in Interview
  • Experience Required: 2–10 years
  • Departments Hiring:
    • Regulatory Affairs (Biologics / Small Molecules)
    • Regulatory Labelling
    • LCM & Global Submissions

🔥 Open Positions at Parexel (Bengaluru)

1. Regulatory Affairs Consultant (Biologics/Small Molecules)

Experience: 7–10 years

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Key Responsibilities

  • Lead and author global and regional regulatory maintenance submissions (US, EU, ROW).
  • Manage lifecycle management for small molecules & biologics including vaccines and mAbs.
  • Handle CMC-related queries and prepare responses to health authorities.
  • Prepare IND, IMPD, DMF, BLA, NDA, MAA gap analyses.
  • Review CMC sections for variations (Type IA/IB/II), renewals, annual reports.
  • Evaluate change controls and regulatory strategy impacts.
  • Manage artwork, labeling updates, and post-approval CMC submissions.
  • Work in RIMS platforms such as Veeva Vault.

Qualifications

  • Strong knowledge of global regulatory procedures (EU/US/ROW).
  • Hands-on experience in CMC authoring, LCM, and HA interactions.
  • Ability to mentor and guide team members.

2. Senior Regulatory Affairs Associate (Biologics/Small Molecules)

Experience: 2–6 years

Key Responsibilities

  • Prepare/author CMC modules, variations, renewals, and annual reports.
  • Manage EU procedures (DCP/MRP/National).
  • Evaluate regulatory impact for change controls and deviations.
  • Handle submission content planning & delivery.
  • Review DMFs, stability data, specifications.
  • Support safety variations and post-approval updates.
  • Work in RIMS (Veeva Vault).

Qualifications

  • RA experience across US, EU, Canada, Australia.
  • Strong understanding of global CMC & regulatory frameworks.
  • Ability to manage LCM & regulatory documentation independently.

3. Senior Regulatory Affairs Associate – Labelling

Experience: 2–6 years

Key Responsibilities

  • Develop and maintain CCDS, USPI, packaging labels.
  • Manage artwork approvals for global markets (US, EU, Switzerland, Canada, Australia).
  • Handle SPL creation, troubleshooting, and management.
  • Execute post-approval labeling submissions & PSUR updates.
  • Manage artwork trackers, document management, and compliance governance.
  • Coordinate with supply chain, quality, and technical teams.

Qualifications

  • Strong command of global labeling regulations.
  • Experience with document systems (Veeva, TVT, Docubridge).
  • Knowledge of CMC components for annual reports.

Why Join Parexel? (Benefits)

  • Work with one of the world’s leading CROs.
  • Exposure to global regulatory strategies and high-impact submissions.
  • Career development through continuous training.
  • Opportunities to work on biologics, vaccines, mAbs & advanced RA processes.
  • Inclusive, supportive work culture.

📝 How to Apply

Join a Team With Heart – Walk-In Drive

  • Date: 20 December 2025
  • Time: 10 AM Onwards
  • Location:
    Arliga Ecoworld, Building No. 5B, 3rd Floor,
    Sarjapur – Marathahalli Outer Ring Road,
    Devarabeesanahalli Village, Varthur Hobli,
    Bangalore East Taluk, Bengaluru – 560103
  • Experience Required: 2–10 Years
  • Departments: Regulatory Affairs, Biologics, Labelling
Parexel Regulatory Affairs Jobs 2025 – Walk-In Drive
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