New · posted Nov 6
AstraZeneca · Pharmaceuticals
Senior Director, Regulatory Affairs Management – Infectious Diseases
- Gaithersburg, MD
- Hybrid
- Full-time
- Director
The role
As Senior Director, Regulatory Affairs Management for the Infectious Disease Unit, you will lead and develop the Regulatory Affairs Management team and set the strategic direction for regulatory delivery across the Infectious Disease portfolios. As a member of the ID Regulatory Affairs Leadership Team, you will partner with Regulatory Affairs colleagues globally to ensure high-quality, compliant submission delivery, strengthen organizational capability, and advance continuous improvement.
In this role, you will help translate scientific innovation into medicines for patients while working with globally connected colleagues who combine scientific and regulatory expertise with a strong commitment to patients.
You will have the opportunity to shape the Regulatory Affairs Management function, develop talent and improve how regulatory work is planned and delivered. Our global community uses data, automation, knowledge sharing and continuous improvement to simplify work and accelerate high-quality outcomes.
What you need
Minimum Qualifications
- Bachelor’s degree in a science related field
- At least 10 years of regulatory affairs experience in the biopharmaceutical industry, a related sector or a health authority, including leadership of regulatory or cross-functional teams
- Proven ability to apply global and regional regulatory requirements to plan and deliver major submissions, manage compliance obligations and support products across the lifecycle
- Demonstrated success leading and developing regulatory professionals through coaching, performance management and succession planning
- Strong project, portfolio and resource management skills, with the ability to set priorities and deliver through global, cross-functional teams
- Strong strategic judgment, risk assessment and decision-making skills, with the ability to influence senior internal stakeholders in complex or ambiguous situations
- Demonstrated experience leading major regulatory submissions, coordinating cross-functional contributors and resolving delivery risks to achieve required quality standards and timelines
- Experience translating regulatory requirements and regional practices into practical submission plans, delivery decisions and project-management approaches
- Excellent written, verbal and interpersonal communication skills with experience influencing key decisions and building effective partnerships across local, global and virtual teams
- Demonstrated success leading organizational change, process improvement and adoption of new ways of working
Accountabilities
- Oversee regulatory project management and operational delivery for development-stage and approved products across the global Infectious Disease portfolio
- Lead and develop the Infectious Disease Regulatory Affairs Management team through direct and indirect people leadership, coaching, performance management, succession planning and recruitment, and represent the team across the broader Regulatory Affairs organization
- Define and implement regulatory submission models that improve efficiency, quality and value, and secure organizational support for their adoption
- Ensure regulatory milestones, submissions and compliance activities are planned, forecast, reported and delivered to required quality standards and timelines
- Build effective internal and external partnerships and represent AstraZeneca, as appropriate, with health authorities, trade associations and other regulatory organizations
- Represent Infectious Disease Regulatory Affairs in driving cross-functional alignment, effective decision-making and execution of strategic and operational objectives
- Lead strategic planning and operational coordination activities, including overseeing team resources and headcount, guiding priorities and assignments as business needs evolve, ensuring regulatory fees and other departmental costs are accurately forecasted, monitored and managed to support delivery within approved budget targets, contributing to business cycle planning, and supporting organizational readiness
- Ensure accurate Infectious Disease Regulatory Affairs resource and cost projections are developed in collaboration with departmental leadership and functional partners for timely integration into enterprise-level processes and other purposes
- Serve as a key business partner to Regulatory Affairs leadership by driving cross-functional alignment, enabling effective governance and decision-making, and ensuring execution of key strategic and operational objectives
- Monitor evolving global and regional regulatory submission operational requirements, assess their implications for the Infectious Disease portfolio and advise stakeholders on strategic operational opportunities, risks and required actions
- Lead the development and improvement of global regulatory policies, processes and capabilities, promoting knowledge sharing and consistent, efficient ways of working across the Regulatory Affairs Management community
- Model AstraZeneca values and foster an inclusive, courageous and high-performing team that delivers effectively across functions, geographies and cultures
Desirable Qualifications
- Advanced degree or further professional qualifications in a relevant discipline
- Experience with infectious disease products, including vaccines, antivirals, antibacterials or monoclonal antibodies
- Knowledge of AstraZeneca’s business, processes and Regulatory Operating Model
- Experience across multiple therapeutic areas or within regulatory operations, drug project delivery, or compliance in a global context
- Budget management experience and commercial acumen; experience developing business cases and tracking benefits for larger programmes
- Facilitation skills and experience leading cross-functional workshops or governance forums
- Experience anticipating emerging regulatory practices and translating them into strategic opportunities, risk mitigations or improved ways of working for pharmaceutical and biological products
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.
We work in person an average of at least three days each week to strengthen connection, collaboration, bold thinking and pace, while maintaining flexibility based on individual and business needs.
Pay and benefits
$218,000 – $327,000 a year
Employer providedSo, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
401(k) plan
Paid vacation and holidays
Paid leaves
Medical, prescription drug, dental and vision coverage
Short-term incentive bonus
Equity-based long-term incentive program
Where you'll work
Gaithersburg, MDHybridOpen in Maps (opens in a new tab)
More jobs in Gaithersburg, MD
From the posting
About AstraZeneca
Date Posted
05-Nov-2026
Closing Date
30-Nov-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.
Equal opportunity, accessibility and legal noticesAstraZeneca's statements, word for word
The annual base pay for this position ranges from $218,058.40 - 327,087.60 USD Annual. 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 pay (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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 40% above the US median for Regulatory Project Management roles at this level.
This roleEmployer provided
Director roles in the US8 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $218,000 | — | $327,000 |
| All US (middle half) | $181,125 | $194,250 | $208,875 |
This role: AstraZeneca's own published range. Comparisons: the base pay employers published on open Regulatory Project Management roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Project Management
The general path across 20 open Regulatory Project Management roles on Regulatory Jobs, with the titles they carry most. Not AstraZeneca's own promotion track.
Career resources on Regulatory Project Management
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership18
- Regulatory submissions9
- Quality systems and risk4
- GMP and compliance3
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Project Management work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
AstraZeneca on Regulatory Jobs
- 40
- Open roles
- 40
- Distinct roles
- 11
- Locations
By discipline
- Quality16 40%
- Clinical14 35%
- Regulatory10 25%
By level
- Director23 57%
- Associate & Specialist11 28%
- Senior & Principal4 10%
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Senior Director, Regulatory Affairs Management – Infectious Diseases at AstraZeneca
Applications close December 1. $218K–$327K a year, employer provided.