US Regulatory Lead

Amgen • Thousand Oaks, CA

7d

About The Position

Amgen's US Regulatory Affairs team provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules. The Local Regulatory Representative (Manager) is assigned to one or more Amgen products and plans and executes the Regulatory strategies for that product(s) in their country(ies). The assigned products typically have medium complexity programs/strategies and medium impact to Amgen. This role involves aligning local regulatory requirements with Amgen’s corporate standards, providing local input to and executing regulatory strategies, and planning and managing local regulatory submissions in compliance with corporate standards and local regulatory requirements. The position also provides guidance on local mechanisms to optimize product development and regulatory approvals, ensures local labels are developed and maintained in line with local legislation and Amgen standards, and ensures and supports local regulatory product compliance. The role acts as the point of contact with regulatory agencies and supports and provides input into the global regulatory strategy for assigned products.

Requirements

• Doctorate degree OR Master’s degree and 3 years of US Regulatory experience OR Bachelor’s degree and 5 years of US Regulatory experience OR Associate’s degree and 10 years of US Regulatory experience OR High school diploma / GED and 12 years US Regulatory
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Managerial experience may run concurrently with the required technical experience referenced above.

Nice To Haves

• Understanding of drug development.
• Knowledge of Regulatory principles.
• Regulatory submissions experience and experience interacting with regulatory agencies (FDA)
• Working knowledge of U.S. legislation/regulations relating to medicinal products and applicable regulatory principles
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• Knowledge and experience in the US regulatory environment relevant for product area and development stage.
• 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.
• Working with policies, procedures, and SOP’s.
• Cultural awareness and sensitivity to achieve results across both regional, country and international borders.

Responsibilities

• 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.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Ensure and support local regulatory product compliance (e.g., IMR, PMCs, and agency commitments).
• Act as the point of contact with regulatory agencies.
• Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Strategic Plans, labeling documents, etc.
• Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
• With general supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.
• Ensures regulatory submissions are made on time and meet Amgen’s 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).
• Manages the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.
• Advises Global teams on local regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives.
• As part of the Global Regulatory Team (GRT), provides regulatory direction/expertise on local regulatory mechanisms to optimize product development (e.g., expediting studies, Orphan Drug Designations, expedited regulatory designations, compassionate use, and pediatric plans).
• Acts as the point of contact with regulatory agencies in fulfilling local obligations.
• Participates/contributes to local agency interactions and their preparation.
• 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.
• Assists locally in Healthcare Compliance activities where applicable.
• Participates in local regulatory process improvements, initiatives and training.
• Oversees external vendor/contractor relationships where applicable.
• Assists locally in Healthcare Compliance, QA or pharmacovigilance activities where applicable.
• 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.
• Mentors and/or advises other(s) Local Regulatory Representatives at more junior levels.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed