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Novo Nordisk

Regulatory Affairs & Pharmacovigilance Associate

Novo Nordisk

Regulatory Affairs & Pharmacovigilance Associate ensuring regulatory compliance and driving pharmacovigilance activities. Involves monitoring regulatory environment and providing expert insights to stakeholders.

Posted 7/6/2026full-timeKuala Lumpur • 🇲🇾 MalaysiaJuniorMid-LevelWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in regulatory affairs and pharmacovigilance, with a strong understanding of regulatory requirements and hands-on experience in regulatory submissions and labeling variations. Excellent communication and interpersonal skills facilitate effective interactions with Health Authorities and support adherence to legislation and internal SOPs.

Highest-signal resume keywords
Regulatory AffairsPharmacovigilanceRegulatory SubmissionsCommunication SkillsInterpersonal Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory RequirementsRegulatory SubmissionsLabeling VariationsAssessment of Registration Files
Soft Skills
Excellent CommunicationInterpersonal Skills
Industry Keywords
Life SciencesPharmacyHealth AuthoritiesSOPs

About the role

Key responsibilities & impact
  • Ensuring adherence to relevant legislation and internal SOPs
  • Overseeing the assessment and submission of registration files
  • Contributing to local regulatory proposals
  • Maintaining close interactions with Health Authorities

Requirements

What you’ll need
  • Bachelor's degree in Life Sciences, Pharmacy or a related field
  • Proven experience in regulatory affairs and pharmacovigilance
  • Strong understanding of regulatory requirements
  • Hands-on experience with regulatory submissions and labelling variations
  • Excellent communication and interpersonal skills

Benefits

Comp & perks
  • Health Authority interactions
  • Developing, reviewing and updating labelling and promotional content
  • Internal PV training
  • Managing safety reporting