License Management Specialist

  • Full time
  • View on Map
  • @GiftAbled posted 1 year ago
  • Posted : November 23, 2022 -Accepting applications
  • View(s) 143

Job Detail

  • Job ID 40526
  • D&I Classifications

  • D&I Classifications PWDs
  • PwDs All
  • Job Specifics

  • Experience 3 Years
  • Gender Any
  • Qualifications GraduatePost Graduate

Job Description

Accountability/Interdependence: Accountable for initiation of regulatory activities according to plan, product license maintenance, strategy execution and operations for regional and local products closely aligned with the HQ Global Regulatory Therapeutic Areas Manage and coordinate preparation of regulatory documentations to support regulatory submission activities (e.g. variations, renewals, answers to objections) Organize and coordinate the liaison with cross functional stakeholders in the dossier generation process for license management activities, incl. external partner(s) Support in authoring as adequate Derive project plan for regulatory deliverables e.g. Renewal Procedures, PSR submission, Variation applications Track submission roll-out & status, perform follow-ups & approval announcements, and maintain dossier lists to ensure regulatory compliance for all dossier submissions worldwide Perform quality checks and control for respective dossiers Support Module 1 preparation, as well provision of Certificates and Statements Maintain regulatory systems and ensure data compliance (RIMS, CARA etc.) To provide any other ad-hoc support to activities executed at REC, envisaging that:
-Relevant training has been successfully completed upfront
-The necessary regulatory, system, product or process knowledge has been provided
-Skills and competencies required for the ad-hoc tasks completion are in line with the agreed REC skill set Such additional

Work Experience

5-6 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role
Minimum 3 years of Regulatory affairs experience

Impact: Prepare dossiers and execute actions that support license maintenance for business continuity as well as product compliance on the markets, and that meet company’s and health authorities’ requirements Enable representatives from all major disciplines involved to reach agreement on the license management strategy and approach

Complexity: Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs
The role will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced License management personnel


Degree in a Life Science or a related discipline, preferably MSc or education in Regulatory Affairs

Required skills