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Associate Regulatory Professional I

2+ years
Not Disclosed
10 April 9, 2025
Job Description
Job Type: Full Time Education: M.Sc /M.Pharm /Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title: Associate Regulatory Professional I

Category: Regulatory Affairs
Department: IOSO Regulatory Affairs – OCE
Location: Not specified (assumed global/regional office)


Position Summary

Novo Nordisk is seeking an Associate Regulatory Professional I to join its IOSO Regulatory Affairs – OCE team. This role focuses on supporting country-specific submissions and ensuring that product changes meet regulatory requirements across various regions.


Key Responsibilities

  • Assist in the compilation, submission, and approval of NDA, LCM, and post-approval changes for assigned countries.

  • Support affiliates in keeping local regulatory requirements updated in accordance with evolving guidelines.

  • Maintain effective stakeholder relationships and ensure transparent communication.

  • Ensure regulatory compliance and provide strategic product direction to internal teams.

  • Interact with regulatory agencies, respond to queries, and help expedite registration approvals.

  • Serve as a regulatory liaison throughout the product lifecycle, managing impact assessments for production and label modifications.


Qualifications

Required

  • Minimum 2+ years of experience in Regulatory Affairs or a related pharmaceutical industry function.

  • Master’s degree in Pharmacy, Science, Medicine, or a relevant field.

  • Intermediate knowledge of pharmaceutical regulatory frameworks and global compliance landscapes.

  • Familiarity with regulatory systems/tools (used in submissions and compliance tracking).

  • Solid cross-functional understanding of Regulatory Affairs and related business areas.


About the Department

The IOSO Regulatory Affairs – OCE team ensures regulatory compliance for both new submissions and product changes. The team plays a pivotal role in securing approval for clinical trials, new medicines, devices, and digital health solutions, while expanding access to existing therapies. Located at Novo Nordisk headquarters, this department is known for its collaborative and fast-paced culture.


About Novo Nordisk

Novo Nordisk is a global healthcare leader with a 100-year legacy, dedicated to combating serious chronic illnesses. The company serves over 40 million patients daily and is recognized among the top 20 companies by market cap globally. With 72,000+ employees, Novo Nordisk fosters innovation, diversity, and a shared mission of creating a healthier world.


Application Instructions

Submit your CV and motivational letter via the official Novo Nordisk careers portal.

Deadline: 14th April 2025


Disclaimer

Beware of fraudulent job offers. Novo Nordisk does not charge fees or request personal purchases during the recruitment process. All official communication will come from authorized Novo Nordisk platforms.


Inclusion Statement

At Novo Nordisk, inclusion isn’t optional — it’s essential. The company is committed to being not just the best in the world, but the best for the world by fostering a workplace that reflects the diverse backgrounds, cultures, and perspectives of its global community. Together, we’re life changing.