Regulatory Affairs Specialist

2 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Regulatory Specialist

We are seeking a highly skilled Regulatory Specialist to join our team. This role will involve managing the regulatory life cycle of drug products, including pre and post approval processes.

Key Responsibilities:
  • Managing regulatory submissions, including preparation and delivery of regulatory maintenance submissions from a global and/or regional perspective.
  • Working knowledge of EU/US regulatory procedures, including post approval requirements, as well as regional trends and legislations.
  • Handling CMC related health authority queries and preparing documentation for Variation procedures.
  • Providing regulatory impact assessments for change proposals and identifying required documentation for EU submissions.
  • Executing and maintaining submission delivery plans, submission content plans, and proactively providing status updates to stakeholders.
  • Preparing, reviewing, and submitting safety variations to Health Authorities and performing post Approval CMC related updates.
Requirements:
  • Around 2-4 years of relevant experience in handling pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.
  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
  • Strong communication skills and ability to guide and mentor team members.
  • Ability to work independently and closely with cross-functional members with aligned product responsibilities.
What We Offer:
  • Opportunity to work with a dynamic team in a fast-paced environment.
  • Chance to develop and grow your career in a growing industry.
  • Competitive compensation and benefits package.
Additional Information:
  • Working experience in Regulatory Information Management Systems like Veeva Vault is an added advantage.
  • Familiarity with global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in ICH countries is desired.

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