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Regulatory Affairs Specialist - Vaf180

Product Life Group
Product Life Group
5+ years
Not Disclosed
10 March 26, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/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

Regulatory Affairs Specialist – VAF 180 (PLG)
Location: Denmark, Finland, Norway (Remote Possible)
Category: Quality & Compliance, Regulatory Affairs & Operations
Contract Type: Permanent

Responsibilities:

Submission and Approval Process:

  • Prepare and submit Technical/Site Transfer Applications.

  • Prepare and submit Marketing Authorisation Applications (MAA).

Lifecycle Maintenance:

  • Prepare and submit documentation for post-approval applications, including Variations, Renewals, MAH Transfers/COAs, and Labeling.

  • Manage artwork generation, labeling, creation, and updates of product information.

Compliance:

  • Monitor and maintain up-to-date knowledge of regulations for DK, FI, IS, NO, and SE.

  • Ensure compliance with all regulatory processes to maintain readiness for internal and external audits.

  • Ensure compliance with the regulations of Nordic agencies (Fimea, DKMA, IMA, NOMA, MPA).

Communication:

  • Act as a liaison between PLG, PLG clients, and regulatory agencies.

  • Support internal requests for information.

Experience and Skills:

  • Minimum 5 years of relevant experience in DK, FI, IS, NO, and SE regulations.

  • Experience managing artwork generation, labeling, and updating product information.

  • Experience with MLA, MAA, CTD, Variations, Renewals, Labeling, and MAH Applications.

  • Knowledge of Nordic languages (DK, SE, NO, FI, or IS) is a plus.

  • Proficiency with software packages and databases such as Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat, etc.

  • Strong organizational and communication skills.

  • Ability to prioritize and deliver high-quality work.

  • Experience in people management/coordination is a plus.

  • Experience in promotional/non-promotional activities is a plus.