Senior Regulatory Affairs Expert

5 days ago

Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000
Regulatory Affairs Specialist

We are seeking a seasoned Regulatory Affairs Specialist to join our team. As a key member of the regulatory department, you will be responsible for ensuring compliance with regulatory requirements and facilitating smooth market access.

About This Role
  • This role is ideal for an experienced professional with 10-15 years in Regulatory Affairs (RA) and at least 6 years in regulated markets such as the USA, EU, UK, or CA.
  • Multiple market experience is highly valued.

Responsibilities:

  • Act as a regulatory lead, overseeing the execution and delivery of all RA projects.
  • Assist in and perform dossier drafting and compilation for all markets.
  • Perform quality checks on all output from the RA team.
  • Responsible for all regulatory submissions from the RA team.
  • Represent project status to the client and the RA Head of Department (HOD).
  • Mentor less experienced or new staff members.

Requirements:

  • 6+ years of experience in regulatory market (USA/EU/CA/UK) dossier submission.
  • Excellent written and verbal English communication skills.
  • Proven team handling experience.
  • Familiarity with eCTD submissions.

Benefits:

  • The opportunity to work with a dynamic team.
  • A challenging and rewarding role that offers opportunities for growth and development.

Others:

  • The ability to make a real impact in the regulatory field.

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