Regulatory Affairs Director, Global Regulatory Strategy

AstraZeneca • Gaithersburg, MD

1d

About The Position

Typical Accountabilities: • Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions • Provides strategic regulatory advice support for product developments regional therapy area • Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known • Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents • Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations • Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities • Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project • Ensures all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory personnel in markets have an appropriate knowledge of quality and compliance • Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration Typical People Management Responsibility (direct / indirect reports): • Approximate number of people managed in total (all levels) - 0-5 • Matrix Manager – (projects/dotted line) What is the global remit? (how many countries will the role operate in?): • 4 or more countries at a minimum of 40% of time Education, Qualifications, Skills and Experience: • Essential: Bachelor’s Degree in Life Science or related discipline, advanced degree a plus.; Significant experience of regulatory drug development, manufacture, commercialisation or equivalent.; Proven successful leadership and project management experience; Broad background of experience of working in several groups in regulatory affairs or experience at a health authority.; Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance • Desirable: Significant Regulatory Experience across global projects and regions; Strong commercial awareness; Problem solving skills; Focus on delivery and results; Excellent strategic influencing and negotiation; Develops collaborative working relationships Key Relationship to reach solutions: • Internal (to AZ or team): AZRA LT members and their direct reports; ISMO EMT and Area 2 Management teams; Other functions (R&D,GM ,Operations and other global); R&D and ISMO functions; Marketing Company Presidents • External (to AZ): External Trade Association members; Health Authorities in Area 1 and 2 markets Compensation Pay Range: 186,232.80 - 279,349.20 USD Annual The annual base pay (or hourly rate of compensation) for this position is outlined above. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 07-Jan-2026 Closing Date 30-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. For over three decades, patients and their caregivers have been at the center of everything we do. Every day, we are inspired to follow the science and think differently to create better outcomes for them and their families. Our mission is driven by understanding who they are as unique individuals, not solely defined by their diseases. We’re a leading rare disease company with a diversified projects. Our pioneering legacy in rare diseases is rooted in being the first to translate the complex biology of the complement system into transformative medicines over the past three decades. Today, we continue to push the boundaries of science and deepen our understanding of rare diseases with patient-centricity at the core. This knowledge allows us to innovate and evolve into new areas where needs are unmet and provide an opportunity to help people fully live their best lives.

Requirements

• Bachelor’s Degree in Life Science or related discipline, advanced degree a plus.
• Significant experience of regulatory drug development, manufacture, commercialisation or equivalent.
• Proven successful leadership and project management experience
• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority.
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance

Nice To Haves

• Significant Regulatory Experience across global projects and regions
• Strong commercial awareness
• Problem solving skills
• Focus on delivery and results
• Excellent strategic influencing and negotiation
• Develops collaborative working relationships

Responsibilities

• Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions
• Provides strategic regulatory advice support for product developments regional therapy area
• Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known
• Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents
• Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations
• Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities
• Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
• Ensures all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps.
• Provide support and advice on training and development to ensure all regulatory personnel in markets have an appropriate knowledge of quality and compliance
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Benefits

• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program (salaried roles)
• to receive a retirement contribution (hourly roles)
• commission payment eligibility (sales roles)
• 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: Director
• Number of Employees: 5,001-10,000 employees