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 in other essential commercialization governance bodies.

• Create the Global Regulatory Strategic Plan and contribute regulatory insights to the product’s Global Strategic Plan.

• Collaborate with GRT members to construct a global regulatory strategy that facilitates product development, registration, and lifecycle maintenance.

• Identify and convey regulatory risks.

• Represent the Global Regulatory Affairs (GRA) on the product team.

• Develop registration strategies and plans to secure regulatory approval and product labeling.

• Provide regulatory guidance in the formulation of the core data sheet to align commercial goals with the available and anticipated scientific data, regulatory guidance, and precedents.

• Lead the planning and execution of global regulatory submissions (e.g., clinical trial applications, marketing applications, label extensions, CMC changes).

• Ensure the consistency of evidence-based global product communications (e.g., regulatory submission documents).

• Monitor and evaluate the impact of relevant global regulations, guidance, and the current regulatory landscape.

• Ensure that guidance on regulatory mechanisms to enhance product development (e.g., expediting First-in-Human studies, Orphan Drug status, Fast Track designation, conditional/accelerated approval, compassionate use, and pediatric plans) is assessed and integrated into the global regulatory strategy.

• Effectively communicate well-defined and successful regulatory strategies throughout the organization to ensure expectations are clear.

• Facilitate effective communications with regulatory agencies by leading core regulatory and cross-functional teams (e.g., GRTs, filing teams).

• Attend key regulatory agency meetings that could influence the 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.

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

• Or 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/clinical information.

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

• Proficiency in conflict resolution and devising a course of action.

• Cultural awareness and sensitivity to achieve global outcomes.

• Strong planning and organizational skills.

• Ability to prioritize and manage multiple tasks.

• Competence in making complex decisions and solving problems.

• Ability to navigate ambiguity.

• Strong 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, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where possible.