About the role
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Audit Strategy, Global Development to join our Global Development Quality Assurance (GDQA), supporting our Global Development organization in a remote work mode. In this role, you will lead risk-based audit strategy programs and oversee compliance across therapeutic areas, studies, and audit activities while collaborating with Global Development teams, auditors, and cross-functional stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
UK Remote - Ireland Remote
Discover your role:
Lead risk-based audit planning across therapeutic areas and studies
Drive strategic audit programs using risk indicators from study teams
Ensure audits align with approved programs and scheduled timelines
Manage audit outcomes to identify trends and communicate risks
Represent quality assurance on complex cross-functional initiatives
Deliver reports and metrics to Global Development leadership
You collaborate effectively with stakeholders across global functions
You navigate ambiguity while prioritizing multiple complex activities
10-20% travel might be required
This role requires:
Bachelor’s degree with 8+ years of relevant industry experience
5+ years of GCP audit strategy or audit experience
Knowledge of FDA, EU, and ICH GCP regulations and guidance
Experience supporting or participating in regulatory inspections
Strong project management and stakeholder management capabilities
Excellent written and verbal communication skills with senior audiences
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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 required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
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. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
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.
Salary Range (annually)
€86,800.00 - €141,200.00Skills & Tags
Aplyr's read
Regeneron Pharmaceuticals is a biotechnology leader focused on innovative medicines for serious diseases, attracting talent in scientific, regulatory, and commercial roles.
What's promising
- •Regeneron is at the forefront of biotechnology with a strong pipeline of innovative medicines.
- •The company offers diverse roles across scientific, regulatory, and commercial functions, indicating robust growth.
- •Regeneron's commitment to R&D is evident in its substantial investment in cutting-edge technologies.
What to watch
- •The competitive biotechnology field requires constant innovation, posing sustainability challenges.
- •Regeneron's success heavily depends on regulatory approvals, which can be unpredictable.
- •The company faces significant competition from other biotech firms in drug development.
Why Regeneron
- •Regeneron has a distinctive focus on antibody-based medicines, setting it apart in the biotech industry.
- •The company is renowned for its proprietary VelociSuite technologies, enhancing drug discovery.
- •Regeneron's collaborative culture fosters innovation and cross-disciplinary teamwork in drug development.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Regeneron
Regeneron Pharmaceuticals is a leading biotechnology company that discovers, develops, and commercializes innovative medicines for serious diseases.
