Global Regulatory Affairs Director – Inflammation and Rare Disease

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

📋 Description

• Formulate and implement the global regulatory product strategy.

• Lead Global Regulatory Teams (GRTs).

• Act as the Regulatory representative on the product team and key commercialization governance bodies.

• Create the Global Regulatory Strategic Plan and offer regulatory insights into the product’s Global Strategic Plan.

• Identify and convey regulatory risks.

• Develop strategies and plans for regulatory approval and product labeling.

• Provide regulatory guidance in the creation of the core data sheet.

• Oversee the planning and execution of global regulatory filings, including clinical trial applications, marketing applications, label extensions, and CMC changes.

• Ensure consistency in evidence-based global product communication and regulatory submission documents.

• Monitor and evaluate relevant global regulations, guidance, and the overall regulatory landscape.

• Evaluate and integrate regulatory mechanisms such as FIH studies, Orphan Drug, Fast Track, conditional/accelerated approval, compassionate use, and pediatric plans.

• Communicate regulatory strategies across the organization.

• Lead core regulatory and cross-functional teams to facilitate effective communications with regulatory agencies.

• Participate in key regulatory agency meetings that influence global product strategy.

• Represent Amgen Regulatory on external partnership teams at the product level.

⛳️ Requirements

• Doctorate degree with 4 years of regulatory experience in biotech or science.

• Alternatively, a Master’s degree with 7 years of regulatory experience in biotech or science.

• Or a Bachelor’s degree with 9 years of regulatory experience in biotech or science.

• Proven ability to lead and develop effective teams.

• Excellent communication skills, both verbal and written.

• Capability to comprehend and convey scientific and clinical information.

• Skill in anticipating and addressing future strategic issues and uncertainties.

• Proficiency in conflict resolution and formulating courses of action.

• Cultural awareness and sensitivity to achieve global objectives.

• Strong planning and organizational skills.

• Ability to prioritize and manage multiple tasks effectively.

• Competence in making complex decisions and solving problems.

• Ability to navigate ambiguity.

• Negotiation skills.

🏝️ Benefits

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

• Group medical, dental, and vision 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 models where feasible.

• Career development opportunities.

• Financial plans with opportunities to save towards retirement or other goals.

• Emphasis on work/life balance.