Senior Regulatory Affairs Lead – LCM & Submissions

AstraZeneca; Selangor; On-site; MYR 120,000 - 180,000; Full time

Job summary

AstraZeneca is seeking a Senior Regulatory Affairs Specialist to manage end-to-end lifecycle activities for assigned markets. You will coordinate dossier preparation, submission processes and Health Authority interactions, ensuring country-specific content aligns with global strategies.

You will work with MC teams, iRAMs, iRADs and iCMC to deliver high-quality, country-ready packages and maintain regulatory records across RIM/ERV systems in a fast-paced, multicultural environment.

Qualifications

• University degree in pharmacy, science, chemistry, biology, engineering or a related discipline.
• Relevant biopharmaceutical regulatory experience, including hands-on experience in established-product maintenance and country dossier preparation.
• Knowledge of post-approval submissions, local administrative requirements, Health Authority query management, approval implementation and regulatory data maintenance.
• Ability to work across CMC and non-CMC content and to collaborate effectively with MCs, International iRAMs, iRADs and iCMC.
• Strong project coordination, attention to detail, problem-solving, written communication and stakeholder-management skills.
• Proficiency in English and ability to operate effectively in a multicultural, matrix and high-volume environment.

Responsibilities

• Plan and deliver assigned product LCM activities in line with market plans and local requirements.
• Prepare, compile and customise submission dossiers, including Module 1 content and local forms.
• Coordinate CMC and non-CMC content with International iRAMs, iRADs and iCMC; identify gaps and secure sources.
• Execute or support timely submission according to the market operating model and maintain submission evidence.
• Track milestones and coordinate responses with MC and international partners.
• Coordinate labeling customization, artwork coordination and labeling maintenance where applicable.
• Support product licence maintenance and MAH-related operational activities for established products.
• Coordinate translations of Health Authority communications and dossiers with final MC validation.
• Maintain regulatory-system records (RIM, ERV) and apply regulatory intelligence to LCM changes.
• Provide status reporting, risk escalation and decision records to MC, CoE leadership and international partners.

Skills

Project coordination

Attention to detail

Problem solving

Written communication

Stakeholder management

English proficiency

Education

University degree

Tools

Veeva RIM

ERV

Regulatory platforms

Job description

AstraZeneca is seeking a Senior Regulatory Affairs Specialist to manage end-to-end lifecycle activities for assigned markets. You will coordinate dossier preparation, submission processes and Health Authority interactions, ensuring country-specific content aligns with global strategies.

You will work with MC teams, iRAMs, iRADs and iCMC to deliver high-quality, country-ready packages and maintain regulatory records across RIM/ERV systems in a fast-paced, multicultural environment.