Senior Manager GD GCP Auditing (UK)

Regeneron Pharmaceuticals, Inc.; Dublin; Remote; EUR 144,000 - 191,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager GD GCP Auditing to join the Global Development Quality Assurance team in a remote work model.

You will lead risk-based quality auditing activities, collaborate with Global Development teams, external partners, and quality stakeholders, and support regulatory inspections to ensure GCP compliance. Ideal candidates have 8+ years in industry, 5+ years of direct GCP audit experience, and strong knowledge of FDA/EU/ICH/GCP requirements.

Qualifications

• Bachelor’s degree with 8+ years of relevant industry experience; Master’s degree preferred.
• At least 5 years of direct Good Clinical Practice audit experience.
• Expert knowledge of FDA regulations, European Union regulations, ICH guidance, and GCP requirements.
• Experience with process, site, vendor, and partner audits.
• Willingness to travel 30-40% domestically and internationally.

Responsibilities

• Lead end-to-end GCP audits across internal and external global activities.
• Schedule, conduct, report, and follow up on routine and directed audits.
• Develop and execute risk-based audit programs for assigned clinical studies.
• Identify compliance issues and drive process improvements and standardization.
• Representing Quality Assurance on complex compliance projects and initiatives.
• Interpret policies, standards, and regulations to address critical issues.
• Support regulatory inspections and inspection room activities.
• Build trusted stakeholder partnerships in a dynamic environment.

Skills

GCP auditing

Audit leadership

Regulatory knowledge

Stakeholder management

Education

Bachelor's degree

Master's degree preferred

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager GD GCP Auditing to join our Global Development Quality Assurance team, supporting our global development organization in a remote work model. In this role, you will lead risk-based quality auditing activities and strengthen GCP compliance while collaborating with Global Development teams, external partners, and quality stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: United Kingdom

Discover your role:

Lead end-to-end GCP audits across internal and external global activities.

Schedule, conduct, report, and follow up on routine and directed audits.

Develop and execute risk-based audit programs for assigned clinical studies.

Identify compliance issues and drive process improvements and standardization.

Representing Quality Assurance on complex compliance projects and initiatives.

Interpret policies, standards, and regulations to address critical issues.

Support regulatory inspections and inspection room activities.

You thrive in a dynamic environment and build trusted stakeholder partnerships.

This role requires:

Bachelor’s degree with 8+ years of relevant industry experience; Master’s degree preferred.

At least 5 years of direct Good Clinical Practice audit experience.

Expert knowledge of FDA regulations, European Union regulations, ICH guidance, and GCP requirements.

Experience conducting audit types including process, site, vendor, and partner audits.

Experience with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations.

Ability to independently manage complex GxP compliance issues and high-value priorities.

Strong leadership skills with experience interfacing with senior leaders.

Excellent project management, stakeholder management, collaboration, and negotiation skills.

Strong problem-solving, written, and verbal communication skills.

Ability to work independently, take initiative, and perform effectively in ambiguous environments.

High attention to detail, accuracy, and organizational awareness.

Willingness to travel 30-40% domestically and internationally.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who’ll thrive here. It's a two-way conversation, not a one-way interview.

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

Our hiring process

From application to your first day — here's how it works.

1. EXPLORE

Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.

2. APPLY

See something you like? Submit your application for the role that fits your background and goals.

3. CONNECT

We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.

4. DECISION

After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.

5. WELCOME

Once you accept, we'll help you prepare for day one - from paperwork and office details to relocation when applicable. You'll have the support you need to start strong.

Stay connected

Be part of what’s next in science

Hear about new opportunities and stories across our teams.