Senior Associate – Regulatory Professional, Obesity and Related Conditions

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and implement U.S. regulatory submissions in alignment with Amgen's corporate standards and FDA regulations.

• Facilitate submission readiness by coordinating contributions, monitoring deadlines, and ensuring that all deliverables are accurate, complete, and submitted punctually.

• Maintain regulatory documentation and records, which include the preparation, delivery, and electronic archiving of submission materials and communication with agencies.

• Develop and uphold documentation regarding product regulatory history, such as IMR, as needed.

• Assist with U.S. labeling initiatives, including reviewing source text to support updates for U.S. labeling.

• Aid in the evaluation of promotional and non-promotional materials as necessary and in compliance with internal policies.

• Organize and conduct quality control on briefing documents and other materials for meetings with regulatory authorities.

• Support interactions with the FDA and serve as a contact point as required to meet product-specific responsibilities.

• Assist in addressing inquiries from health authorities by coordinating contributions, tracking actions, and ensuring document preparedness.

• Gather and share regulatory information among regulatory colleagues and cross-functional teams.

• Stay informed about new U.S. legislation, guidance, and regulatory policies; escalate and distribute pertinent updates.

• Participate in cross-functional and team governance activities, including GRT support such as agenda preparation and minute-taking.

⛳️ Requirements

• Master’s degree in biology, life science, health science, or regulatory science with a biology focus; OR bachelor’s degree in a science field with 2 years of relevant experience; OR associate’s degree in a science discipline with 6 years of relevant experience; OR high school diploma/GED in a science field with 8 years of relevant experience.

• Experience in a regulated industry (e.g., biotech/pharma, medical device, clinical research, healthcare).

• Background in supporting programs related to Obesity, Diabetes, or related metabolic conditions through scientific or clinical work.

• Excellent written and verbal communication skills.

• Strong organizational abilities; adept at managing multiple tasks, timelines, and stakeholders.

• Proven attention to detail and a focus on document quality.

• Capability to identify, communicate, and escalate risks or issues as needed.

• Familiarity with document management and archiving procedures in a regulated environment.

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work arrangements where feasible.

• Opportunities for career development.

• Support for work/life balance.