New · posted Nov 6
AstraZeneca · Pharmaceuticals
Senior Regulatory Affairs Director- Infectious Diseases
- Gaithersburg, MD
- Hybrid
- Full-time
- Director
The role
AstraZeneca - Infectious Diseases
At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of people, where the burden of disease is greatest. During the COVID-19 pandemic, we played an important role as part of a truly global effort to respond to a new and unprecedented challenge. We will continue to advance science in infectious disease therapies and work with partners to drive improvements in public health and ensure our science reaches millions more people.
The Senior Regulatory Affairs Director (SRAD) leads the global regulatory strategy for complex products. They aim to secure rapid approval that meets business, market, and patient needs. The SRAD offers strategic leadership and has expertise in global regulatory science, drug development processes, and strategies for high-profile programs. Familiarity with the disease area is essential to influence cross-functional discussions with Global Product Teams (GPT) and stakeholders. They can serve as the Global Regulatory Lead (GRL) for a product group and also act as a regional lead based on their location.
Your strategic leadership skills and deep understanding of global regulatory science from early to late-stage development into commercialization strategy will be crucial in influencing cross-functional discussions and guiding high-profile development programs, as well as interacting with Global Health Authorities. Are you prepared to take on the Global Regulatory Lead role and drive innovative strategies for regulatory success?
Here, regulatory leaders help transform pioneering science into therapies that reach patients faster—by driving innovative approaches, smart risk-taking, and disciplined execution. You will work across a rich pipeline with colleagues who value curiosity and kindness alongside ambition, bringing unexpected teams together to unlock knowledge and sharpen strategy.
What you need
- Master’s degree in a science-related field required. An advanced degree is preferred; equivalent relevant knowledge and experience may also be considered.
- At least 10 years experience or equivalent of regulatory drug development including successful contribution to a major regulatory approval at a global level.
- Experience in Infectious Diseases is strongly preferred.
- Must have previous experience in leading Major Health Authority interactions (e.g., FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).
- Proven leadership and program management experience, as well as the ability to think strategically and critically evaluate risks to regulatory activities.
- Ability to work strategically within a complex, business-critical and high-profile development program.
What you'll do
- Effectively lead or deputise for Therapeutic Area (TA) VP/Regional VP in senior-level interactions internally or externally, including contributions to internal governance
- Develop and implement regulatory strategies for products, ensuring rapid approval with advantageous labeling.
- Lead the planning and construction of global dossiers and core prescribing information.
- Conduct regulatory risk planning and mitigation.
- Serve as the single point of contact and Global Regulatory Affairs representative on Product Development Teams.
- Lead the Global Regulatory Sub-team to ensure regional regulatory needs are incorporated into the Global Regulatory Strategy and ensure execution on strategy.
- Deliver all regulatory milestones, assess regulatory success probabilities, and implement risk mitigation measures.
- Partner with marketing and regional regulatory affairs staff to help shape the environment and Health Authorities' views on relevant topics.
- Lead regulatory staff on complex projects to ensure prioritized objectives are delivered on time and with quality.
- Ensure effective regulatory representation at health authority meetings with clear documentation of discussions.
- Lead the development and updates of the Regulatory Strategy Document for complex projects.
- Monitor changes in the regulatory environment and advise Global Product Teams accordingly.
- Provide regulatory leadership in product in-license/due diligence review, divestment, and withdrawal.
- Lead complex projects designed to improve efficiencies and simplification, spanning cross functional areas.
Pay and benefits
$218,058 – $327,088 a year
Employer providedShort-term incentive bonus
Equity-based long-term incentive program
401(k) plan
Paid vacation and holidays
Paid leaves
Medical, prescription drug, dental and vision coverage
Where you'll work
Gaithersburg, MDHybridOpen in Maps (opens in a new tab)
More jobs in Gaithersburg, MD
From the posting
About AstraZeneca
Why AstraZeneca
Our globally connected community blends cutting-edge technology with deep disease expertise, embraces data and automation to reduce cycle times, and thrives on collaboration that turns complex challenges into concrete outcomes for patients. Your ideas will be heard, your growth supported, and your impact visible in every milestone we achieve.
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.
That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible.
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 salary for this position ranges from $218,058.40 - $327,087.60 USD Annual. However, 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) or to receive a retirement contribution (hourly 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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% above the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Director roles in the US46 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $218,058 | — | $327,088 |
| All US (middle half) | $227,500 | $252,000 | $268,875 |
This role: AstraZeneca's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 89 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not AstraZeneca's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- Regulatory submissions9
- Documentation and SOPs2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- 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
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- 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
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- 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)
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns
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 Regulatory Affairs Director- Infectious Diseases at AstraZeneca
Applications close December 1. $218K–$327K a year, employer provided.