Regulatory Affairs Senior Manager, Regional CoE

Lead the regional Life Cycle Management portfolio ensuring alignment with business priorities agreed service levels and quality and compliance expectations

Manage intake prioritization work allocation capacity visibility and governance of activities transferred from Marketing Company teams

Lead complex or high-impact activities related to dossier customization regulatory submissions national requirements post-approval pathways and CMC change management

Ensure the preparation compilation and quality review of country-ready regulatory packages including Module 1 national forms cover letters declarations local administrative documentation translations and ERV activities where applicable

Execute or support regulatory submissions under the agreed operating model maintain submission evidence and ensure regulatory records remain complete and current

Coordinate the receipt assignment consolidation and timely submission of responses to health authority questions ensuring appropriate involvement of Marketing Companies iRAMs iRADs and iCMC

Oversee approval follow-up activities implementation of variations and commitments regulatory system updates and compliant closure of activities

Where applicable lead regional capabilities for labeling adaptation and implementation ensuring appropriate use of tools templates and quality controls

Design and enhance processes templates national requirements guides artwork coordination workflows and automation opportunities to improve efficiency and right-first-time quality

Identify and manage regulatory CMC supply quality resource and timeline risks recommending and implementing appropriate mitigation measures

Lead the investigation and resolution of portal rejections administrative non-compliance execution failures or schedule deviations including root cause analysis and implementation of corrective actions

Manage performance indicators related to workload volume timeliness right-first-time quality data quality response times to health authority questions implementation and activity closure

Provide matrix leadership coaching knowledge transfer development planning and deployment of specialized expertise within the team

Build strong relationships with Regulatory leaders in Marketing Companies iRAMs iRADs iCMC and partners across Manufacturing Supply Quality Labelling Patient Safety and Regulatory Operations

Ensure activities are executed in accordance with Good Regulatory Practice GRP AstraZeneca policies GxP requirements the Code of Ethics and applicable functional procedures

• Education:
  
  University degree or equivalent professional qualification in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.
• Regulatory
  
  Experience:
  
  Minimum 7 years of extensive experience in regulatory affairs for biopharmaceutical products, including significant responsibility for Life Cycle Management of assigned products, national submissions, labeling, and regulatory CMC activities.
• Multinational
  
  Experience:
  
  Experience working across multiple markets, products, and national regulatory requirements within a regional or international environment.
• Technical Knowledge:
  Strong understanding of post-approval regulatory frameworks, national dossier requirements, health authority procedures, CMC change management, and implementation controls.
• Portfolio Leadership:
  Demonstrated experience leading complex regulatory portfolios and cross-functional matrix teams.
• Stakeholder Management:
  Ability to collaborate, influence, negotiate, and align local, regional, and global teams, as well as technical and functional partners.
• Communication:
  Excellent written and verbal communication skills in English, with the ability to present technical information, risks, alternatives, and recommendations to senior stakeholders.
• Autonomy and Professional Judgment:
  Ability to make operational decisions, set priorities, and manage complex or ambiguous situations with a high degree of autonomy.
• Scientific and Regulatory Judgment:
  Ability to evaluate technical and regulatory information, identify gaps, and provide…