Job Description

Career Category Regulatory



Role: Regulatory Affairs Manager

Organization: Local Regulatory Affairs

The Regulatory Affairs Manager provides country regulatory expertise, plans and executes the Regulatory strategies for Amgen products in Malaysia.

Assist in aligning local regulatory requirements with Amgen's corporate standards.

Provide local input to and execute regulatory strategies.

Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.

Provide guidance on local mechanisms to optimize product development and regulatory approvals.

Collaborate with above country regulatory colleagues to support the regulatory development, registration, and lifecycle management of Amgen molecules.

Monitor changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen.

Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.

Review and approve promotional and non-promotional materials.

Ensure and support local regulatory product compliance.

Manage the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.

Act as the point of contact with the local regulatory agency.

Contribute to process improvement projects/initiatives.

Assists in Healthcare Compliance, QA or pharmacovigilance activities where applicable.

Support local planning and execution for clinical studies in accordance with national legal and regulatory requirements where applicable.

Knowledge and Skills

Knowledge of Regulatory principles.

Working with policies, procedures, and SOP's.

Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.

Knowledge of national legislation and regulations relating to medicinal products.

General awareness of the registration procedures/challenges in the country for CTAs, MAs and all lifecycle management activities.

Knowledge and experience in the country regulatory environment relevant for product area and development stage.

Understanding of drug development.

Demonstrate strong teamwork ability.

Good communication skills - both oral and written.

Good negotiation and Influencing skills.

Ability to understand and communicate scientific/clinical information.

Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

Cultural awareness and sensitivity to achieve results across both regional, country and International borders.

Education & Experience

Registered Pharmacist in Malaysia.

Bachelor's degree and 5 years of directly related experience.

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