Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution

AstraZeneca • Gaithersburg, MD

1d • $135,625 - $203,437 • Hybrid

About The Position

The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This role requires a demonstrated ability to shape and drive end-to-end regulatory strategy across all phases of product development, from early-stage planning through post-market lifecycle optimization. This individual will provide tactical and strategic input and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will serve as a key strategic thought partner to senior leadership, proactively identifying regulatory opportunities and risks that influence portfolio-level decision-making. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

Requirements

• Bachelor's Degree in life science
• Postgraduate degrees relevant to the role (e.g. MSc, PhD, PharmD, MD) a plus
• Additional certification and/or training relevant to the role over the past 7 years in pharmaceutical industry regulatory affairs
• Strong knowledge of US drug development and regulatory policy; excellent scientific and business judgment.
• Demonstrated track record of independently developing and executing US regulatory strategies that have directly contributed to successful regulatory outcomes (e.g., approvals, accelerated pathways, breakthrough designations).
• Extensive experience providing US strategic regulatory advice for the global development of products across multiple stages of development, from IND-enabling through post-approval lifecycle management.
• Experience leading submissions and FDA interactions, including strategic pre-submission planning, advisory committee preparation, and negotiation of regulatory pathways.
• Proven ability to synthesize complex scientific, clinical, and regulatory data into clear strategic positions and actionable plans for senior leadership.
• Ability to manage complex issues and coordinate multiple projects simultaneously.
• Ability to build intra-team relationships and collaborate in a global team environment at all levels of the organization.
• Exceptional interpersonal and written/verbal communication skills, with the ability to communicate complex regulatory strategies, risks and recommendations with clarity, conviction, influencing senior leadership, cross-functional stakeholders, and regulatory authorities.
• Proven track record practicing sound judgment as it relates to risk assessment and strategic decision-making under conditions of regulatory uncertainty.
• Highly conversant and knowledgeable of new and emerging regulations and guidances.
• Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.

Responsibilities

• Working with manager to develop and direct innovative, forward-looking regulatory strategies in support of assigned Alexion portfolio, pipeline and therapeutic areas, ensuring alignment with long-term corporate objectives and evolving regulatory landscapes.
• Serving as US Strategy Lead on assigned programs.
• Acting as submission sub-team lead for US submissions and is core member of Global Regulatory Team (GRT) for assigned programs.
• Driving strategic alignment between US and global regulatory plans to maximize registration success and competitive positioning.
• Providing strategic and tactical advice on regulatory issues for pipeline products; actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
• Influences cross-functional strategic decisions by providing authoritative regulatory intelligence and scenario-based risk analyses.
• Developing, leading, and executing US-specific aspects of regulatory strategy and ensures integration into global regulatory strategy.
• Anticipates regulatory challenges and proactively designs mitigation strategies to protect program timelines and objectives.
• Representing Alexion as point of contact with FDA, including leading the strategic development for regulatory meetings and information package development.
• Strategically shaping FDA engagement plans to advance program goals and secure favorable regulatory outcomes.
• Coordinating submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial application submissions, amendments, etc.
• Monitoring the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
• Translating emerging regulatory trends into actionable strategic recommendations that inform portfolio and pipeline planning.
• Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
• Communicating regulatory strategy, risks, and recommendations with clarity and conviction to senior leadership, cross-functional teams, and health authorities in order to drive alignment, inform decision-making, and support program objectives.
• Ensuring exemplary behavior, ethics and transparency within the company and with regulatory agencies.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior