Director, cmc regulatory affairs Work, Jobs in Cambridge, Eng (with Salaries)

Regulatory Affairs Director
AstraZeneca —Cambridge
- Leadership
- Communication skills
11h
Senior Regulatory Affairs Director
AstraZeneca —Cambridge
- Presentation skills
- Organisational skills
- Leadership
7d
Head Of Food Operations
Medirest —Trumpington
- £65,000 a year
- Full-time
- Continuous improvement
- Food service
- Organisational skills
Medical Director, Medical Safety
Jazz Pharmaceuticals —Cambridge
- £113,600 - £170,400 a year
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
Associate Director, Clinical Operations
Jazz Pharmaceuticals —Cambridge
- Remote
- Master's degree
- Bachelor's degree
- No degree
- Annual leave
9d
Director of IELTS Research
Cambridge University Press & Assessment —Cambridge
- £79,300 - £99,100 a year
- Hybrid work
- Doctoral degree
- English
- AI
- Annual leave
Principal/Head of Nursery - term time only
Millington Road Nursery School —Cambridge
- £45,000 - £50,000 a year
- Full-time
- Management
- Administrative experience
- In-person
- Work from home
- Sick pay
Quick apply
8d
Director, Project Team Lead, Early Research
Flagship Pioneering, Inc. —Cambridge
- Doctoral degree
- Laboratory experience
- Master's degree
(Senior) Global Medical Director, Established Brands
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Leadership
Senior QA Auditor - 60% - 80%
Healx —Cambridge
- Part-time
- Hybrid work
- Analysis skills
- Bachelor's degree
- Travel
- Annual leave
- Work from home
Quick apply
ELT Course Director and ELT teachers - residential summer centre 4-6 weeks guaranteed
ATC Language Schools —Cambridge
- £540 - £685 a week
- Temporary
- English
- Master's degree
- Education
Quick apply
Deputy Development Director
Fitzwilliam College —Cambridge
- Full-time
- Microsoft Office
- Master's degree
- Project management
- Free parking
- Annual leave
14d
Deputy Director of Diagnostics and Cancer
NHS England —Fulbourn
- £112,782 - £129,783 a year
- Full-time
- Annual leave
7d
Head Of Compliance And Quality Assurance
Medirest —Cambridge
- Hotel
- Analysis skills
- Leadership
- Employee discount
5h
Head of Managed Care Records
Central East Integrated Care Board —Ely
- £79,504 - £91,609 a year
- Full-time
- Leadership
- Communication skills
4d
Head of Housing
Hundred Houses Society —Cambridge
- £62,218 a year
- Full-time
- Leadership
- Communication skills
- Negotiation
- Annual leave
- Employee assistance programme
Senior Director of AI and Data Strategy
Abcam —Cambridge
- Full-time
- Sales
- Engineering
- Bachelor's degree
Head of Programmes
Marshall Land Systems Ltd —Cambridge
- Full-time
- Hybrid work
- Engineering
- Project management
- Business
3d
Head of Finance
The Edmund Trust —Cambridge
- £63,207 - £74,156 a year
- Part-time
- Hybrid work
- Management
- Leadership
- Free parking
- Health & wellbeing programme
Quick apply
3d
Director, Translational Science Lead
GlaxoSmithKline —Stevenage
- £178,200 - £297,000 a year
- Full-time
- Doctoral degree
- Business development
- Leadership
- Annual leave

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Regulatory Affairs Director

AstraZeneca -
Cambridge

Apply Now

Job details

11 hours ago

Qualifications

Leadership
Communication skills

Full job description

Location Cambridge, England, United Kingdom Job ID R-256605 Date posted 16/07/2026

Job Title: Regulatory Affairs Director

Location: Cambridge

Salary Competitive

Introduction to role:

Are you ready to shape European regulatory strategy that accelerates innovative oncology medicines to patients and secures the strongest possible labels? This role puts you at the heart of pivotal decisions, where your expertise turns cutting‑edge science into real-world impact across Europe.

As a senior leader in our global regulatory team, you will bring European insight to global strategy and influence how programs advance from early development to launch and beyond. You will partner closely with cross-functional colleagues to craft compelling data packages, steer high-stakes interactions with European regulators, and drive submissions that deliver timely approvals. Could you be the person who translates complex evidence into decisive regulatory outcomes for patients who cannot wait?

Accountabilities:

Own and deliver European regulatory strategy for assigned oncology products to secure rapid approvals with competitive labeling, leveraging expedited pathways and aligning with patient, market and business needs.
Serve as the face of AstraZeneca with the EMA and other European authorities; set engagement strategy, plan and moderate key meetings, lead label discussions and negotiations, and build trusted, influential relationships.
Lead MAA and variation submissions, ensuring the global dossier and core prescribing information are constructed to the highest standard; drive high-quality briefing documents and responses that address scientific and regulatory priorities.
Lead the Global Regulatory Strategy Team as Global Regulatory Lead for early-stage projects or specific indications, or serve as the European lead within the team, bringing clear regional strategy and guidance to global plans.
Provide strategic regulatory advice to Global Product Teams; partner with CMC, Labeling, Regulatory Affairs Managers and affiliates to align development, submission and post-approval activities for maximum patient and business value.
Shape strategy for new indications, novel combinations and complex evidence approaches; contribute to pivotal design choices and end-of-Phase 2 pathways to de-risk and accelerate Phase 3.
Objectively assess emerging data against program aspirations; quantify regulatory risks and mitigations; keep senior leaders informed and adjust strategy to maintain approval speed and label competitiveness.
Lead product maintenance activities for marketed brands, safeguarding supply continuity and compliance across Europe.
Engage with regional affiliates and trade organizations to anticipate evolving guidance and influence emerging regulatory approaches.

Essential Skills/Experience:
An advanced degree in a science related field and/or other appropriate knowledge/experience.
A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.
Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
The ability to think strategically and critically and evaluate risks to regulatory activities.
A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
Ability to work strategically within a complex, business critical and high-profile development program.
Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components.

Desirable Skills/Experience:

Prior experience of regulatory drug development or equivalent, and experience with major Health Authority interactions.
Prior experience with Phase 3 design including end of Phase 2 Health Authority interactions.
Contribution to a regulatory approval including leading response team and labeling negotiations.
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
Experience in relevant therapy area across small molecules and biologics.

Why AstraZeneca:

Here you will join an agile, influential regulatory community that turns bold science into approval-ready strategies. We collaborate across unexpected teams in the same room clinicians, statisticians, CMC, safety and commercial unleashing bold thinking that shapes development from the start. We challenge each other and engage regulators constructively to drive innovative data packages and secure the best possible labels. With advanced tools, growing automation and rich learning pathways, you can push beyond traditional regulatory thinking while knowing we value kindness alongside ambition. Your expertise will directly change the trajectory of medicines for patients who need them most.

What is next!

If you are ready to lead European regulatory strategy that moves life-changing oncology medicines faster and further, step forward and make your impact now!

We are looking forward to your application not later than 31st July 2026

Date Posted

17-Jul-2026

Closing Date

31-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, cmc regulatory affairs jobs in cambridge, eng

Regulatory Affairs Director

Senior Regulatory Affairs Director

Head Of Food Operations

Medical Director, Medical Safety

Associate Director, Clinical Operations

Director of IELTS Research

Principal/Head of Nursery - term time only

Director, Project Team Lead, Early Research

(Senior) Global Medical Director, Established Brands

Senior QA Auditor - 60% - 80%

ELT Course Director and ELT teachers - residential summer centre 4-6 weeks guaranteed

Deputy Development Director

Deputy Director of Diagnostics and Cancer

Head Of Compliance And Quality Assurance

Head of Managed Care Records

Head of Housing

Senior Director of AI and Data Strategy

Head of Programmes

Head of Finance

Director, Translational Science Lead

I want to receive the latest job alerts for director, cmc regulatory affairs in cambridge, eng

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