وصف الوظيفة
Role Overview
Regulatory Affairs Senior Specialist, Regional Centre of Excellence at AstraZeneca, based in the Kingdom of Saudi Arabia.
Company Overview
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world's most serious diseases. AstraZeneca is experiencing significant transformation in the Kingdom of Saudi Arabia, driven by a commitment to advancing healthcare, innovation, and sustainable growth, aligned with Saudi Vision 2030. The organization is investing in talent, digital solutions, and new ways of working to enhance impact on patient outcomes and reinforce leadership in therapeutic areas.
Role Purpose
The Senior Regulatory Affairs Specialist serves as part of the Regional Regulatory Centre of Excellence, an operational delivery arm for Life Cycle Management regulatory activities on behalf of Marketing Companies across multiple markets. The role ensures that medicines reach patients in a timely, safe manner and in compliance with the highest global regulatory standards, by managing the operational delivery of LCM activities for assigned countries or clusters while working closely with Marketing Company teams, iRAMs, iRADs, and international iCMC teams.
Key Responsibilities
Life Cycle Management Planning and Execution
- 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.
- 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 Management
- Monitor review milestones, anticipate Health Authority questions, and coordinate complete, consistent, and timely responses with Marketing Company 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
- Support product license maintenance, operational Marketing Authorization Holder (MAH)-related activities, and divestment or transfer activities for assigned products.
Translation Management
- Coordinate translations of Health Authority communications, approvals, and dossier components, with final validation provided by the responsible Marketing Company.
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 and Risk Management
- 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 Marketing Company 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 Marketing Company teams.
Qualifications & Experience
- Bachelor's degree in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.
- Minimum 4 years of relevant experience in biopharmaceutical regulatory affairs, including hands-on experience supporting assigned products and preparing country-specific dossiers.
- Strong knowledge of post-approval submissions, local administrative requirements, Health Authority query management, approval implementation, and regulatory data maintenance.
- Ability to work with both CMC and non-CMC content and collaborate effectively with Marketing Company teams, iRAMs, iRADs, and iCMC teams.
Skills & Competencies
- Strong project coordination, attention to detail, and problem-solving skills.
- Written communication and stakeholder management capabilities.
- Proficiency in English.
- Ability to operate effectively in a multicultural, matrixed, and high-volume environment.
- Experience with Veeva RIM, ERV, regulatory intelligence platforms, or comparable planning and document management systems (desirable).
- Experience supporting multiple markets, clusters, local distributors, or external submission partners (desirable).
- Experience with digital workflow initiatives, reporting, automation, or continuous improvement programs (desirable).
Additional Information
AstraZeneca is committed to being a Great Place to Work, with an inclusive culture that champions diversity and collaboration, and is committed to lifelong learning, growth, and development. The company embraces diversity and equality of opportunity, and welcomes applications from all qualified candidates regardless of their characteristics. AstraZeneca complies with all applicable laws and regulations on non-discrimination in employment and recruitment, as well as work authorization and employment eligibility verification requirements.