Regulatory Affairs Manager - US Regulatory Lead, Rare Disease
About The Position
The Regulatory Affairs Manager ensures Amgen’s compliance with regulations and laws pertaining to its business, and works with federal, state, and local regulatory agencies on issues affecting the company’s products and services. The role is assigned to one or more Amgen products and plans and executes regulatory strategies for those products in their respective countries. For the US Regulatory Lead, Rare Disease role, the manager supports the Global Regulatory Team in US regulatory activities, including IND development and submission; serves as a contact with regulatory agencies; advises on local mechanisms to optimize product development and regulatory approvals; and plans and manages local submissions in compliance with corporate standards and local requirements. The role also supports local product compliance and labeling, contributes to global regulatory strategy and plans, prepares supporting documentation for regulatory deliverables, manages responses to agency questions, and authors routine regulatory correspondence.
Requirements
- Doctorate degree; or a master’s degree and 2 years of Regulatory Affairs experience; or a bachelor’s degree and 4 years of Regulatory Affairs experience; or an associate degree and 8 years of Regulatory Affairs experience; or a high school diploma/GED and 10 years of Regulatory Affairs experience.
Nice To Haves
- Master’s degree in biology, life science, health science, or regulatory science with a biology curriculum.
- Experience in a regulated industry, science, or clinical practice.
- Strong organizational skills, attention to detail, and ability to handle frequent changes in product activity.
Responsibilities
- Support the Global Regulatory Team in US regulatory activities, including IND development and submission.
- Act as the point of contact with regulatory agencies.
- Provide guidance on local mechanisms to optimize product development and regulatory approvals.
- Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
- Ensure and support local regulatory product compliance, including agency commitments.
- Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
- Support and provide input into global regulatory strategy for assigned products, including Global Regulatory Plans and labeling documents.
- Prepare supporting documentation for regulatory deliverables, including regulatory landscape or strategy research and target product label research.
- Manage the process for responding to regulatory agency questions.
- Provide primary authorship for routine regulatory correspondence.
Benefits
- Retirement and Savings Plan with generous company contributions
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
