US Regulatory Associate - Obesity & Related Conditions

BioSpace; Washington (District of Columbia); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Amgen seeks a Senior Associate, United States Regulatory Professional for Obesity and Related Conditions. This product-facing role provides regulatory leadership in submission creation under supervision, coordinating with global and US teams to ensure timely, compliant deliverables.

You will support health authority interactions, labeling activities, and document management in a regulated biotech environment, driving quality and timely responses across teams.

Qualifications

• Master's degree in biology, life science, health science, or regulatory science with a biology focus.
• Bachelor's degree in science with 2 years related experience.
• Associates degree in science with 6 years related experience.
• High school diploma with 8 years related experience.

Responsibilities

• Coordinate and execute U.S. regulatory submissions per FDA requirements.
• Drive submission readiness by coordinating inputs and timelines for complete and timely submissions.
• Maintain regulatory documentation and records, including preparation, delivery, and electronic archiving of submission content and agency communications.
• Create and maintain product regulatory history documentation (e.g., IMR).
• Support U.S. labeling activities, including review of source text to enable labeling updates.
• Review promotional and non-promotional materials per internal requirements.
• Coordinate and QC briefing documents for meetings with regulatory agencies.
• Support FDA interactions and act as a point of contact as appropriate.
• Support responses to health authority questions by coordinating inputs and ensuring document readiness.
• Collate and communicate regulatory information across regulatory colleagues and cross-functional teams.
• Maintain awareness of emerging U.S. legislation, guidance, and regulatory policy; elevate relevant updates.
• Participate in cross-functional and team governance as needed.

Skills

Strong written and oral communication

Strong organizational skills

Attention to detail

Issue identification and escalation

Regulatory documentation

Cross-functional collaboration

Experience in regulated industry

Education

Master's degree in biology, life science, health science, or regulatory science with biology focus

Bachelor's degree in science with 2 years related experience

Associates degree in science with 6 years related experience

High school diploma with 8 years related experience

Job description

Amgen seeks a Senior Associate, United States Regulatory Professional for Obesity and Related Conditions. This product-facing role provides regulatory leadership in submission creation under supervision, coordinating with global and US teams to ensure timely, compliant deliverables.

You will support health authority interactions, labeling activities, and document management in a regulated biotech environment, driving quality and timely responses across teams.