Senior Regulatory Affairs Specialist, Regional CoE

AstraZeneca plc; Riyadh; Presencial; SAR 180 000 - 300 000; Tempo integral

Resumo da oferta

AstraZeneca plc in Riyadh is seeking a Regulatory Affairs Senior Specialist to join the Regional Centre of Excellence. You will manage lifecycle regulatory activities, coordinate dossier content, and lead HAQ responses across markets from this regional hub.

You will work with MC teams, iRAMs, iRADs, and iCMC teams to ensure timely filings, post‑approval changes, and labeling updates, in a fast‑paced, global environment.

Qualificações

• Bachelor's degree in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.
• Minimum 4 years of regulatory affairs experience in biopharmaceuticals, including dossier work.
• Strong knowledge of post-approval submissions, local requirements, HA query management, and data maintenance.
• Ability to collaborate across MC teams, iRAMs, iRADs, and iCMC teams.
• Fluency in English; capable of working in a multicultural, matrixed environment.

Responsabilidades

• LCM planning and delivery aligned with market plans and global procedures.
• Dossier preparation and customization including country-specific content.
• Coordinate CMC and non-CMC content with international teams.
• Execute or support timely submission of dossiers and evidence.
• Manage Health Authority queries and coordinate responses with partners.
• Track approvals and coordinate post-approval changes and PSURs/PBRERs.
• Coordinate labeling, artwork, and labeling maintenance.
• Support MAH activities, license maintenance, and divestment/transfer actions.
• Oversee translation of HA communications and dossier components.
• Maintain regulatory systems in RIM/ERV and other KPIs.
• Apply regulatory intelligence and communicate risks and opportunities.
• Provide status reporting and drive continuous improvement.

Conhecimentos

Project coordination

Attention to detail

Problem solving

Written communication

Stakeholder management

English language

Formação académica

Bachelor's degree in Pharmacy/Science/Engineering

Ferramentas

Veeva RIM

Descrição da oferta de emprego

AstraZeneca plc in Riyadh is seeking a Regulatory Affairs Senior Specialist to join the Regional Centre of Excellence. You will manage lifecycle regulatory activities, coordinate dossier content, and lead HAQ responses across markets from this regional hub.

You will work with MC teams, iRAMs, iRADs, and iCMC teams to ensure timely filings, post‑approval changes, and labeling updates, in a fast‑paced, global environment.