Senior Specialist, Commercial Regulatory Affairs

Danaher UK

New Delhi, India
On-site
Import license applications and renewals
Post approval change applications
Country specific regulations and guidelines
Danaher UK is seeking a Senior Specialist in Commercial Regulatory Affairs to manage the preparation and submission of import license applications and ensure compliance with regulatory requirements in India and surrounding regions. The position calls for an experienced professional with a background in life sciences, specifically in medical device regulations, and emphasizes a collaborative culture within a leading diagnostics company

Job Summary

  • The Sr. Specialist, Commercial Regulatory Affairs is responsible for preparation, submission and approvals for the Import license applications, renewals, and Post Approval change applications and ensure filings are following Country specific regulations and guidelines, with a focus on India, Sri Lanka and other SWA countries.
  • You will have the opportunity to initiate, prepare and submit product Import license applications, renewals, and Post Approval change applications and ensure filings are following Country specific regulations and guidelines, with a focus on India, Sri Lanka and other SWA countries.
  • The essential requirements of the job include a Degree in a Science / Pharmacy or related field and at least 8-10 years of relevant experience within the registration process in medical devices or IVD industry.

Matching Summary

Match Score: 85

Danaher UK is seeking a Senior Specialist in Commercial Regulatory Affairs to manage the preparation and submission of import license applications and ensure compliance with regulatory requirements in India and surrounding regions. The position calls for an experienced professional with a background in life sciences, specifically in medical device regulations, and emphasizes a collaborative culture within a leading diagnostics company.

Skills & Requirements

Must-have

  • Import license applications and renewals
  • Post Approval change applications
  • Country specific regulations and guidelines
  • Respond to regulatory authority queries
  • Proactive regulatory intelligence

Nice-to-have

  • Collaborate with cross-functional departments
  • Provide regulatory assessments
  • Guidance on labeling and promotional materials
  • Work in a team-based setting

Key Requirements

  • Degree in Science / Pharmacy or related field
  • 8-10 years of relevant experience
  • Well-versed understanding of Indian Medical Device Regulations 2017
  • Experience in matrix organization and international environment
  • Experience in managing people
  • Experience in handling projects independently

Work Rights

Not specified

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