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Manager, Global Regulatory Affairs LCM CMC

1 - 8 years

20 - 24 Lacs

Chennai Pune Delhi Mumbai Bengaluru Hyderabad Kolkata

Posted:8 months ago| Platform: Naukri logo

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Skills Required

Training Office equipment Pharma Agile CMC GMP Subject matter expertise Management Regulatory affairs Quality documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Alvotech is looking to hire a

Manager

for

Global Regulatory Affairs Life-Cycle Management (LCM) Chemistry, Manufacturing, and Controls (CMC).

In this role, you will support life-cycle management of biosimilar products by developing regulatory strategies, representing the CMC regulatory team in cross-departmental projects, and ensuring unified regulatory advice. You will also identify and mitigate regulatory risks, manage high-quality documentation, participate in health authority interactions, and collaborate with external partners.

Key Responsibilities:

  • Assist in developing regulatory LCM CMC strategies.
  • Represent CMC regulatory team in cross-functional teams.
  • Communicate unified GRA-aligned messages at interdisciplinary meetings.
  • Identify and mitigate product CMC regulatory risks.
  • Assess and approve change controls for responsible products.
  • Review and manage high-quality CMC documentation.
  • Understand and apply ICH, FDA guidelines, GMP, and quality requirements.
  • Participate in health authority interactions.
  • Interface with external partners to support commercial success.
  • Support development of regulatory excellence tools and processes.
  • Ensure efficient and transparent working environment within GRA.
  • Keep projects on track and within budget.

Job Requirements:

  • PhD (1-3 years), MS (4-6 years), BS (6-8 years) in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent.
  • Subject matter expertise in regulatory affairs and related activities.
  • Previous experience in life cycle management and variation filing for US, EU.
  • Ability to work in matrix teams and diverse cultures.
  • Ability to work effectively in a fast-paced dynamic environment.
  • Fluency in English is essential; other languages are beneficial.

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