Regulatory Affairs Senior Specialist, Regional CoE

Plan and execute assigned LCM activities in line with market plans agreed priorities internal objectives local requirements and applicable global procedures

Compile and customize submission dossiers including country-specific Module 1 content national forms declarations cover letters administrative documents and supporting records nbsp

Coordinate with international iRAMs iRADs and iCMC teams to identify content gaps and ensure timely availability of approved source documents and technical responses

Execute or support the timely submission of dossiers according to the market operating model including administrative steps and submission evidence where applicable

Monitor review milestones anticipate Health Authority questions and coordinate complete consistent and timely responses with MC and international partners

Obtain and track LCM approvals or notifications and coordinate implementation of variations renewals commitments and other post-approval changes including PSURs PBRERs and safety data cutoffs

Manage label customization artwork coordination implementation workflows compliance verification and maintenance of labeling where applicable

Support product license maintenance operational MAH-related activities and divestment or transfer activities for asigned products

Coordinate translations of Health Authority communications approvals and dossier components with final validation provided by the responsible MC

Maintain accurate and timely records in RIM ERV and other required regulatory systems in accordance with established procedures standards and KPIs

Apply relevant LCM regulatory intelligence through approved channels escalating changes that may impact strategy content timelines supply or compliance

Provide transparent status reporting risk escalation and decision records to MC teams CoE leadership iRAMs iRADs and iCMC teams

Contribute to the development of standard templates playbooks dashboards automation initiatives and lessons learned to reduce duplication of effort and workload for MC teams

• Education:
  
  Bachelor's degree in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.
• Regulatory
  
  Experience:
  
  Minimum 4 years of relevant experience in biopharmaceutical regulatory affairs, including hands-on experience supporting assigned products and preparing country-specific dossiers.
• Technical Knowledge:
  Strong knowledge of post-approval submissions, local administrative requirements, Health Authority query management, approval implementation, and regulatory data maintenance.
• Cross-Functional Capability:
  Ability to work with both CMC and non-CMC content and collaborate effectively with MC teams, iRAMs, iRADs, and iCMC teams.
• Professional
  
  Competencies:
  
  Strong project coordination, attention to detail, problem-solving, written communication, and stakeholder management skills.
• Language and Working Environment:
  Proficiency in English and the ability to operate effectively in a multicultural, matrixed, and high-volume environment.