Regulatory Affairs Director – Global Regulatory Leader, Rare Disease

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

📋 Description

• Formulates a Global Regulatory Strategic Plan by integrating regional regulatory strategies and providing regulatory insights into the Global Strategic Plan.

• Represents GRA in PT and EGT to ensure the formulation of product registration strategies and development plans aimed at securing regulatory approval and product labeling.

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

• Oversees the development, review, and approval of the target product label (TPL).

• Gathers insights from GRT members (e.g., RRLs, RA CMC, Safety, etc.) to formulate a global regulatory strategy that supports product development, registration, and lifecycle management.

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

• Ensures consistency in evidence-based global product communication (e.g., regulatory submission documents).

• Conducts contingency regulatory planning and risk assessments for global product development strategies and agency interactions.

• Monitors and evaluates the impact of relevant global regulations, guidance, and the current regulatory landscape.

• Provides guidance on regulatory mechanisms to optimize product development (e.g., expediting FIH studies, Orphan Drug Designation, Breakthrough Therapy or PRIME designations, Fast Track, conditional/accelerated approval, compassionate use, and pediatric plans) to be assessed and integrated into the global regulatory strategy.

• Consistently communicates well-defined, effective regulatory strategies throughout the organization to ensure understanding of expectations.

• Develops strategies that present innovative alternatives while articulating associated risks.

• Communicates Amgen’s stance consistently across functions and all documentation.

• Cultivates the ability to articulate and teach the likelihood of regulatory success based on proposed strategies.

• Enhances the ability to accurately predict expectations and outcomes from regulatory agencies.

• Directs global regulatory agency interaction strategies in collaboration with regional colleagues.

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

• Guarantees consistent communication of product information to Health Authorities.

• Participates in key regulatory agency meetings that could influence the global product strategy.

• Leads the GRT in developing and executing team objectives.

• Provides coaching and mentoring to GRT members.

• Incorporates input from regional regulatory representatives into GRT and regulatory plans.

• Communicates and ensures alignment of global functional and cross-functional goals and objectives.

• Represents Global Regulatory Affairs on key commercialization teams (e.g., PT, EGT, GST).

• Represents Amgen GRA on external partnership teams at the PT level.

• Delivers education and training on regulatory strategies and compliance matters to other PT functions.

• Ensures regulatory compliance for products (e.g., IMR, PMCs, pediatric and other agency commitments).

• Advocates for Amgen/GRAAS by establishing strong relationships with key external stakeholders, including senior regulatory agencies, trade associations, and influential professional bodies.

• Engages externally to influence the regulatory legislative environment in alignment with Amgen's policy priorities for the therapeutic area.

• Conducts regulatory due diligence assessments of licensing/acquisition opportunities as assigned by management.

⛳️ Requirements

• Doctorate degree and 4 years of directly related experience OR Master’s degree and 8 years of directly related experience OR Bachelor’s degree and 10 years of directly related experience.

• Minimum of 4 years of experience in managing personnel and/or leadership roles in steering teams, projects, programs, or directing resource allocation.

• Proven ability to lead teams effectively.

• Excellent communication skills, both verbal and written.

• Capability to comprehend and convey scientific/clinical information.

• Familiarity with regulatory activities and their impact on projects and processes.

• Ability to foresee and address future strategic issues and uncertainties.

• Proficient in conflict resolution and developing strategies that lead to advantageous outcomes, showcasing influencing and negotiation skills.

• Cultural awareness and sensitivity to achieve results across regional and international boundaries.

🏝️ 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 feasible.