Regulatory Affairs Manager – Oncology

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

📋 Description

• Develop and convey the regulatory promotional stance for both approved and pipeline Oncology products, as well as the associated disease state.

• Offer strategic guidance for communications related to products and diseases, along with relevant activities.

• Analyze the current regulatory landscape to ensure accurate and non-deceptive messaging to the healthcare community, patients, and the general public.

• Act as the lead for regulatory advertising and promotion for both approved and pipeline Oncology products and disease states.

• Confirm that all deliverables align with the product label, comply with US FDA regulations and guidelines, and follow Amgen's SOPs and policies.

• Identify opportunities and challenges that affect the US product strategy based on shifting competition, regulatory changes, and clinical findings.

• Assess the appropriate levels of evidence necessary to substantiate product claims.

• Provide mentorship to Manager-level promotional reviewers.

⛳️ Requirements

• Doctorate degree OR Master’s degree with 2 years of industry experience OR Bachelor’s degree with 4 years of industry experience OR Associate’s degree with 8 years of industry experience OR High school diploma / GED with 10 years of industry experience.

• Minimum of 2 years of experience in Oncology.

• Proficiency in interpreting government regulations, policies, and guidelines.

• Strong skills in clinical data analysis.

• Capacity to utilize judgment and data to articulate and communicate positions on intricate issues.

• Experience working collaboratively within large, cross-functional teams.

🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan featuring generous company contributions, as well as group medical, dental, and vision insurance, life and disability coverage, and flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for career development.

• Support for work/life balance.

• Sponsorship for this role is not guaranteed.