Regulatory Affairs Manager - US Regulatory Lead, Rare Disease

Amgen • Thousand Oaks, CA

3d

About The Position

The Regulatory Affairs Manager ensures Amgen’s compliance with regulations and laws pertaining to its business, and works with regulatory agencies on issues affecting the company’s products and services. Assigned to one or more Amgen products, this role plans and executes regulatory strategies for those products in their countries. The position supports U.S. regulatory activities and contributes to global regulatory strategy, submissions, product compliance, labeling, and agency communications.

Requirements

• Doctorate degree; or master’s degree and 2 years of Regulatory Affairs experience; or bachelor’s degree and 4 years of Regulatory Affairs experience; or associate degree and 8 years of Regulatory Affairs experience; or 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.
• Regulated industry, science, or clinical practice experience.
• Strong organizational skills, attention to detail, and ability to deal with frequent changes in product activity.

Responsibilities

• Support the Global Regulatory Team in U.S. regulatory activities, such as 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.
• Assist the Global Regulatory Lead by preparing supporting documentation for regulatory deliverables, including regulatory landscape research and target product label or regulatory strategy research.
• Manage the process for responding to regulatory agency questions.
• Provide primary authorship for routine regulatory correspondence.

Benefits

• Retirement and Savings Plan with company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Time-off plans.
• Flexible work models where possible.
• Career development opportunities.

What This Job Offers

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