Senior Regulatory Affairs Lead — Global LCM & Submissions

AstraZeneca; Selangor; Presencial; MYR 250.000 - 450.000; Jornada completa

Descripción de la vacante

AstraZeneca is seeking a Regulatory Affairs Senior Manager to lead the Regional CoE's end-to-end LCM delivery, ensuring country-ready submissions and compliant strategies. You will collaborate with MC regulatory leaders, iRAMs, iRADs and iCMC to translate international content into country-ready packages.

The role requires senior regulatory judgment, strong project management and the ability to navigate multi-market submissions with a focus on efficiency and quality.

Formación

• University degree or equivalent professional qualification in pharmacy, science, chemistry, biology, engineering or a related discipline.
• Demonstrated extensive biopharmaceutical regulatory experience with established-product LCM and country submissions.
• Proven ability to lead complex regulatory delivery portfolios and cross-functional teams.

Responsabilidades

• Lead the CoE LCM portfolio and delivery scorecard aligned with regional priorities and compliance expectations.
• Own demand intake, prioritisation, and governance for LCM activities transferred from MC teams.
• Lead complex dossier customization and submission delivery with expert advice on country requirements and post-approval pathways.
• Establish robust relationships with MC regulatory leaders, iRAMs, iRADs, iCMC and cross-functional partners to improve efficiency.
• Ensure CoE teams prepare country-ready LCM packages including Module 1 and administrative content.
• Drive standardisation and automation to reduce MC workload and improve right-first-time quality.
• Govern health authority questions and track submission progress and timelines.
• Oversee variation management, RIM/ERV updates, and regulatory record maintenance.

Conocimientos

Regulatory leadership

LCM lifecycle

GxP compliance

HA relationships

Project management

English communication

Educación

Bachelor's degree in pharmacy/science/engineering

Herramientas

Veeva RIM

ERV

Regulatory planning tools

Descripción del empleo

AstraZeneca is seeking a Regulatory Affairs Senior Manager to lead the Regional CoE's end-to-end LCM delivery, ensuring country-ready submissions and compliant strategies. You will collaborate with MC regulatory leaders, iRAMs, iRADs and iCMC to translate international content into country-ready packages.

The role requires senior regulatory judgment, strong project management and the ability to navigate multi-market submissions with a focus on efficiency and quality.