Director of regulatory affairs Work, Jobs in Henham, Ess (with Salaries)

Senior Regulatory Affairs Director
AstraZeneca —Cambridge
- Presentation skills
- Organisational skills
- Leadership
10d
Regulatory Affairs Director
AstraZeneca —Cambridge
- Leadership
- Communication skills
3d
Medical Director, Medical Safety
Jazz Pharmaceuticals —Cambridge
- £113,600 - £170,400 a year
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
Director, Translational Science Lead
GlaxoSmithKline —Stevenage
- £178,200 - £297,000 a year
- Full-time
- Doctoral degree
- Business development
- Leadership
- Annual leave
(Senior) Global Medical Director, Established Brands
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Leadership
Associate Director, Portfolio Project Management
Bicycle Therapeutics —Cambridge
- Full-time
- Hybrid work
- PMP
- Project management
- Organisational skills
- Annual leave
- Employee assistance programme
Quick apply
3d
Quality and Regulatory Manager
Advanced Healthcare Technology Ltd —Waltham Cross
- £50,000 - £60,000 a year
- Full-time
- No degree
- Organisational skills
- In-person
- Free parking
Quick apply
12d
Senior QA Auditor - 60% - 80%
Healx —Cambridge
- Part-time
- Hybrid work
- Analysis skills
- Bachelor's degree
- Travel
- Annual leave
- Work from home
Quick apply
Associate Director, Regulatory Legal Counsel
Illumina —Cambridge
- £110,600 - £166,000 a year
- Full-time
- Management
- English
- Travel
Senior Manager, Market Access Specialty Care
Sobi —Cambridge
- Full-time
- Remote
- Doctoral degree
- English
- Master's degree
Quick apply
Senior Director, Biostatistics
Bicycle Therapeutics —Cambridge
- Full-time
- Hybrid work
- Management
- Leadership
- Annual leave
- Employee assistance programme
Quick apply
13d
Global Marketing Associate Director – Breast Cancer (12 months FTC – Maternity Cover)
AstraZeneca —Cambridge
- Management
- Sales
- Bachelor's degree
13d
Senior Medical Writer - FSP
IQVIA —Cambridge
- Microsoft Word
- Doctoral degree
- Master's degree
Senior Director, Business Development
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Excel
- English
- Annual leave
- Life insurance
Quick apply
Medical Director, UK and Ireland
Mundipharma —Cambridge
- Full-time
- English
- Leadership
Director Safety Surveillance & Risk Management (12 months fix term contract)
Viatris —Hatfield
- Full-time
- Hybrid work
- Bachelor's degree
- Time management
- Health & wellbeing programme
- Employee assistance programme
GXP Audit and Inspection Director
Mundipharma —Cambridge
- Full-time
- Bachelor's degree
- Leadership

Other jobs to consider

Find your next job by exploring related positions.

In-house FCA Compliance Lead
Beyond Co —Newmarket
Help shape compliance foundations that support future product expansion, ensuring the framework is flexible enough to accommodate a growing suite of regulated…
£65,000 - £75,000 a year
Quick apply
Programme Leader - EAP - University of East London
Malvern International Plc —London
Collaborate with the centre and university departments and services to support the broader academic and digital skills agenda.
£44,974.95 a year
Quick apply

I want to receive the latest job alerts for director of regulatory affairs in henham, ess

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Senior Regulatory Affairs Director

AstraZeneca -
Cambridge

Apply Now

Job details

10 days ago

Qualifications

Presentation skills
Product development
Organisational skills
Leadership
FDA regulations

Full job description

Location Cambridge, England, United Kingdom Job ID R-256197 Date posted 09/07/2026

Senior Regulatory Affairs Director

Introduction to role:

The Senior Regulatory Affairs Director (RAD) leads the development and implementation of global regulatory strategy for one or more products of high complexity and visibility, and may serve as Franchise Global Regulatory Lead (GRL) on complex programmes with multiple indications. Where applicable, this role also operates in a dual capacity, serving as a regional lead based on location, in addition to GRL responsibilities.

Central to this role is ensuring that regulatory strategy delivers rapid approvals with competitive labeling, aligned to the properties of the product(s) and the needs of the business, markets, and patients. The Senior RAD provides team leadership across a large Global Regulatory Strategy Team, including coaching and mentorship, while driving global regulatory deliverables in line with GPT goals.

Externally, the Senior RAD builds and maintains relationships with key regulatory stakeholders, leveraging these to sustain competitive advantage. This is a visible position, recognised as a senior leadership role within the Regulatory Community.

Accountabilities:

Accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of high complexity and/or spanning multiple indications. This includes providing Regulatory leadership on franchise products with multiple indications and development programs. May serve in dual-role as GRL and regional RAD.
Ensure that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
Lead a Global Regulatory Strategy Team (GRST) responsible for specific indications/programs within the franchise, key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Participate in coaching and performance feedback to members of your GRST.
Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and accountable for all Regulatory activities.
Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. You will lead preparation of the regulatory strategy document and target product labeling.
Demonstrate strategic leadership skills thereby contributing to effective product development.
Lead, participate, and promote non-project functional or cross-functional initiatives and engage externally on the corresponding topics as needed. Lead the development of novel regulatory tools and technology.
Ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands.
Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
May have line management responsibilities.

Essential Skills/Experience:

An advanced degree in a scientific discipline with extensive relevant experience/knowledge.
Deep understanding of global regulatory science and integration with program strategy.
Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
Proven experience leading regulatory, cross-functional teams, and stakeholder management.
Successful leadership of at least one global regulatory marketing approval as GRL across major regions (US and EU) including leading response team and labeling negotiations.
Ability to think strategically and critically and evaluate risks to regulatory activities.
Previous experience in leading major Health Authority interactions.
Excellent oral, written, and presentation skills.
Strong organisational skills.
Ability to work in a fast-paced environment in a hands-on fashion.
Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.

Desirable Skills/Experience:

Experience with FDA advisory committee and CHMP oral explanation.
Experience working on due diligence activities and in a business alliance environment.
Experience in leading and growing people through coaching or mentorship.
Contribution to non-project business initiatives (e.g. at a portfolio or cross functional level).
Experience in Oncology (small molecules and biologics) is preferred.

Why AstraZeneca:

Join a science-led company advancing life-changing medicines with urgency and precision, where bold thinking meets rigorous execution to solve complex health challenges. Here, unexpected teams come together to spark new ideas, and diverse perspectives are not just welcomed but relied upon to unlock smarter, faster paths for patients.

Recognising the importance of individualised flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

Date Posted

10-Jul-2026

Closing Date

24-Jul-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

Apply Now

Refine Your Search

director of regulatory affairs jobs in henham, ess

Senior Regulatory Affairs Director

Regulatory Affairs Director

Medical Director, Medical Safety

Director, Translational Science Lead

(Senior) Global Medical Director, Established Brands

Associate Director, Portfolio Project Management

Quality and Regulatory Manager

Senior QA Auditor - 60% - 80%

Associate Director, Regulatory Legal Counsel

Senior Manager, Market Access Specialty Care

Senior Director, Biostatistics

Global Marketing Associate Director – Breast Cancer (12 months FTC – Maternity Cover)

Senior Medical Writer - FSP

Senior Director, Business Development

Medical Director, UK and Ireland

Director Safety Surveillance & Risk Management (12 months fix term contract)

GXP Audit and Inspection Director

Other jobs to consider

I want to receive the latest job alerts for director of regulatory affairs in henham, ess

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected