Job Description

Career Category Regulatory



Local Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products and may support an LRR or lead the planning and execution of Regulatory strategies for a program(s) under the supervision of an experienced Local Regulatory Lead. The product(s) assigned have low/medium complexity programs/strategies and medium impact to Amgen.

Assist in aligning local regulatory requirements with Amgen\xe2\x80\x99s corporate standards.

Provide national/regional (as applicable) input to and implement regulatory strategies.

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

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

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

Ensure and support local regulatory product compliance (eg, IMR, PMCs, and agency commitments)

Act as the point of contact with regulatory agencies.

Strategic and Execution

Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.

With close supervision, performs the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.

Ensures regulatory submissions are made on time and meet Amgen\xe2\x80\x99s corporate and local regulatory requirements.

Creates, reviews, and approves source text for country labeling, and owns the country artwork based on source text.

Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).

Reviews and approves the promotional and non-promotional materials.

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

Monitors the external regulatory environment to help inform/advise in the regulatory decision making.

Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments).

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

HEALTH AUTHORITY INTERACTIONS

Acts as the point of contact with regulatory agencies in fulfilling local obligations.

Participates/contributes to local agency interactions and their preparation.

COMMUNICATION AND COLLABORATION

Works closely with cross-functional colleagues in the country, Affiliate or Hub to align on strategy and deliver country/Affiliate/Hub goals.

Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.

Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.

Partners with peers to ensure consistency on procedures.

Acts as contact and create relationships with Agency staff on specific product assignment (if applicable).

Establishes regular contacts and interactions with Distributors (if applicable).

Provide SME support to process improvement projects/initiatives.

COUNTRY SPECIFIC ACTIVITIES

Assists locally in Healthcare Compliance activities where applicable.

Participates in local regulatory process improvements, initiatives, and training.

Oversees external vendor/contractor relationships where applicable.

REGULATORY RESEARCH

Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products

Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement

Scientific and Technical

Knowledge of Regulatory principles.

Working with policies, procedures and SOP\xe2\x80\x99s.

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

General knowledge of national legislation and regulations relating to medicinal products.

Understanding of drug development.

Others

Demonstrate ability to work in teams.

Ability to understand and communicate scientific/clinical information.

Education & Experience (Basic)

Master\xe2\x80\x99s degree (scientific area) OR

Bachelor\xe2\x80\x99s degree (scientific area) and 2 years of directly related experience.

Education & Experience (Preferred)

In-depth regulatory experience in the applicable country(ies).

In-depth knowledge of country(ies) legislation and regulations relating to medicinal products

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Amgen