GSK

Regulatory Affairs Manager, CIS/Asia Cluster

GSK

full-time

Posted on:

Location Type: Hybrid

Location: Poznan • Poland

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Salary

💰 PLN 210,000 - PLN 350,000 per year

About the role

  • Management of marketing authorizations (MAs) and coordination of associated activities for assigned markets including the primary interface with Content Delivery and 3rd Party Service Provider to support regulatory submissions to local regulatory agencies
  • Effective planning and tracking of regulatory activities for defined markets
  • Ensures that GSK Labeling (PI/PIL) is compliant with MA and with regulatory requirements and available in local language as applicable
  • Co-ordinates the completion of local language translations by 3rd Party CRO (as applicable)
  • Ensures product information is compliant with MA and product pack changes are implemented in compliance with regulations and aligned to supply chain planning
  • Co-ordinates all regulatory submissions and commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines
  • Co-ordinates with Content Delivery the management of product registration documents and agency correspondence in regulatory databases and repositories
  • Builds and maintains effective relationships with, and provide considered regulatory advice, leadership, and expertise to cross functional stakeholders
  • Effective communication, collaboration, planning and oversight of Regulatory Third-Party service providers to achieve Regulatory objectives and meet compliance standards
  • Participation and compliance in internal and external projects and activities
  • Lead Resource management, objective setting, performance and development of staff, talent reviews and succession planning, through a coordinated, well managed, strategically aligned program
  • Monitor and keep abreast of changes in the regulatory environments. Provide intelligence to relevant stakeholders and central teams on potential impact changes in the regulatory environment in the region

Requirements

  • Proven relevant experience in Regulatory Affairs
  • 3-4 years line management experience
  • Degree in scientific discipline (life sciences / pharmacy / professions aligned to medicine)
  • Fluent English (speaking and writing)
  • Effective collaboration and negotiation with regulatory agencies
  • Strong project management skills
  • Excellent communication and analytical skills
  • Attention to details
Benefits
  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
  • Hybrid working model (40% monthly time)
  • Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working from the office, short Fridays option, health & well-being activities)
  • Life insurance and pension plan
  • Private medical package with additional preventive healthcare services for employees and their eligible
  • Sports cards (Multisport)
  • Possibilities of development within the role and company’s structure
  • Personalized learning approach (internal trainings, mentoring, access to online training platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
  • Supportive community and integration events
  • Modern office with creative rooms, fresh fruits every day
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory submissionsmarketing authorizationsproduct registration documentslocal language translationscompliance standardsregulatory databasesproject management
Soft Skills
effective communicationcollaborationleadershipnegotiationattention to detailanalytical skills
Certifications
degree in scientific disciplinelife sciencespharmacy