Director of regulatory affairs Work, Jobs in Berkhamsted, Hrt (with Salaries)

Associate Director, Regulatory Project Manager
CSL Behring —Maidenhead
- £170,000 - £210,000 a year
- Full-time
- Doctoral degree
- PMP
- Master's degree
Vice President, Medical Affairs Rare Diseases
Recordati —Hemel Hempstead
- £245,552 - £368,358 a year
- Full-time
- Hybrid work
- Management
- Doctoral degree
- English
- Annual leave
Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology
Recordati —Hemel Hempstead
- Full-time
- Hybrid work
- English
- Quality control
- Travel
7d
Director, Regulatory Affairs, Europe
GE HEALTHCARE —Chalfont Saint Giles
- Engineering
- Master's degree
- Bachelor's degree
(Senior) Director Global Medical Affairs
BioNTech AG —London
- £168,100 - £318,300 a year
- Full-time
- Doctoral degree
- Travel
- Leadership
Director of Public Affairs, UK
Abbott Laboratories —Maidenhead
- Full-time
- Bachelor's degree
- Communication skills
Director - Regulatory Platforms
CSL Behring —Maidenhead
- Full-time
- Computer Science
- Bachelor's degree
- Travel
10d
Director, Product and Clinical Training (Hybrid)
Insulet Corporation —London
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Regulatory Strategy Director, Renal
Vertex Pharmaceuticals —Paddington
- Full-time
- Bachelor's degree
- Organisational skills
- Leadership
Associate Director, Global Medical Affairs (2-year contract)
BioNTech AG —London
- Full-time
- Doctoral degree
- Project management
- Travel
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
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International plc —Marlow
- £80,000 - £140,000 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Associate Director, Clinical Trial Disclosure & Transparency
CSL Behring —Maidenhead
- Full-time
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Communication skills
23h
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
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International —Marlow
- £66,814 - £134,641 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Quick apply
Executive Director, Global Patient Safety Sciences Delivery
Regeneron —Uxbridge
- Management
- Doctoral degree
- Master's degree
- Annual leave
Country Medical Director, UK and Ireland
Gilead Sciences —London
- Full-time
- Hybrid work
- Management
- Research
- Recruiting
10d
Director Global Access Policy and Government Affairs
BioNTech AG —London
- Full-time
- Analysis skills
- Bachelor's degree
- Travel
Head of Global Labelling
CSL Seqirus —Maidenhead
- Full-time
- Leadership
Marketing Sr Director and Launch Lead - Metabolic and Dermato-Oncology Franchise
Recordati —Hemel Hempstead
- Full-time
- Hybrid work
- Management
- Marketing
- English

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director of regulatory affairs jobs near berkhamsted, hrt

Associate Director, Regulatory Project Manager

CSL Behring -
Maidenhead

Apply Now

Job details

Full-time
£170,000 - £210,000 a year

Qualifications

Doctoral degree
PMP
Master's degree
Bachelor's degree
Business

Full job description

Entity: CSL Behring

Job Category: Research Development & Sciences

Job Family: R&D Project Management

Job Type: Full Time

Location: Maidenhead, England, United Kingdom

Employer Reference: R-282451

Job Description

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Associate Director, Regulatory Project Manager? The job is in our Waltham MA, King of Prussia PA, Glattbrugg Switzerland or Maidenhead UK Office. This is a hybrid position and is onsite three days a week.

You will lead global regulatory project planning and execution across CSL’s product portfolio, ensuring timely delivery of submissions and improvement initiatives aligned with GRA strategy. This role oversees submission coordination, and cross-functional collaboration to meet global health authority requirements and drive operational excellence.

Main Responsibilities & Accountabilities:

Regulatory Project Leadership

Lead end-to-end project management of regulatory initiatives and improvement projects (initiation through closure) within budget, scope, and timelines.
Develop, execute, and monitor project plans, risk logs, communication strategies, and status reporting.

Submission Coordination

Oversee regulatory submissions per CSL’s Global Submission Management Process.
Lead submission team meetings, content planning, tracking in RIMS, and ensure on-time, compliant submissions.
Liaise with global, regional, and local teams for successful execution

Continuous Improvement & Governance

Manage improvement projects portfolio in alignment with GRA strategy and executive priorities.
Support quarterly reporting to Portfolio Committee and implement process efficiencies.
Contribute to governance, best practices, and standardization across regulatory operations.

Management & Collaboration

May be required to manage Regulatory Project Managers
Leads cross-functionally with Regulatory, Clinical, Manufacturing, POE (GPM) and external partners.
Mentor junior project managers and support training on submission processes and tools.
Liaise with Regulatory Policy to ensure awareness and incorporation of policy changes into Regulatory strategy, planning, and execution

Qualifications & Experience

Bachelor’s degree in Life Sciences or Business required; advanced degree (MSc, PhD, MBA) and PMP certification preferred.
7+ years of experience in pharma/biotech industry with a focus on biologics and regulatory affairs.
7+ years’ experience managing global, cross-functional projects in a matrix environment.
Strong knowledge of global regulatory submission processes, drug development lifecycle, and project governance.
Demonstrated success in delivering complex projects on time and within scope.

The expected base salary range for this position at hiring is $170,000-210,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

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About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Apply Now

Refine Your Search

director of regulatory affairs jobs in berkhamsted, hrt

Associate Director, Regulatory Project Manager

Vice President, Medical Affairs Rare Diseases

Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology

Director, Regulatory Affairs, Europe

(Senior) Director Global Medical Affairs

Director of Public Affairs, UK

Director - Regulatory Platforms

Director, Product and Clinical Training (Hybrid)

Regulatory Strategy Director, Renal

Associate Director, Global Medical Affairs (2-year contract)

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

Associate Director Global CMC QU – Clinical GMP/GDP

Associate Director, Clinical Trial Disclosure & Transparency

Quality and Regulatory Manager

Associate Director Global CMC QU – Clinical GMP/GDP

Executive Director, Global Patient Safety Sciences Delivery

Country Medical Director, UK and Ireland

Director Global Access Policy and Government Affairs

Head of Global Labelling

Marketing Sr Director and Launch Lead - Metabolic and Dermato-Oncology Franchise

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Job Description

About CSL Behring

Our Benefits

You Belong at CSL

Equal Opportunity Employer

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