أخصائي أول الشؤون التنظيمية، مركز التميز الإقليمي

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

Dossier Preparation and Customization: Compile and customize submission dossiers, including country-specific Module 1 content, national forms, declarations, cover letters, administrative documents, and supporting records.

CMC and Non-CMC Content Coordination: Coordinate with international iRAMs, iRADs, and iCMC teams to identify content gaps and ensure timely availability of approved source documents and technical responses

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

Health Authority Query (HAQ) Management: Monitor review milestones, anticipate Health Authority questions, and coordinate complete, consistent, and timely responses with MC and international partners.

Approval Tracking and Implementation: 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.

Labeling Coordination: Manage label customization, artwork coordination, implementation workflows, compliance verification, and maintenance of labeling where applicable.

License Maintenance and MAH Activities: Support product license maintenance, operational MAH-related activities, and divestment or transfer activities for asigned products.

Translation Management: Coordinate translations of Health Authority communications, approvals, and dossier components, with final validation provided by the responsible MC.

Regulatory Systems Maintenance: Maintain accurate and timely records in RIM, ERV, and other required regulatory systems in accordance with established procedures, standards, and KPIs.

Regulatory Intelligence: Apply relevant LCM regulatory intelligence through approved channels, escalating changes that may impact strategy, content, timelines, supply, or compliance.

Reporting and Risk Management: Provide transparent status reporting, risk escalation, and decision records to MC teams, CoE leadership, iRAMs, iRADs, and iCMC teams.

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

Desired Candidate Profile

Essential Capabilities 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.