Senior Manager Process & Procedures Operations GVP

Regeneron Ireland; Ireland; Hybride; EUR 87 000 - 141 000; Plein temps

Avantages offerts par ce poste

Annual bonuses

Equity awards

Pension benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental,视,

Paid time off

Family support benefits

Résumé du poste

Regeneron Ireland is hiring a Senior Manager to lead development and maintenance of global procedural documents supporting clinical trial delivery. The role collaborates with subject matter experts, functional leaders, and training partners to drive improvements and ensure regulatory alignment.

The position is hybrid with remote UK or Ireland options, travel for team events, and a focus on process governance, training, and audit readiness while advancing Regeneron’s patient-centric mission.

Qualifications

• Bachelor’s or Master’s degree with relevant industry experience and strong procedural writing.

Responsabilités

• Lead development, revision, approval, and implementation of procedural documents for global development processes.
• Partner with SMEs and functional teams to drive process improvements and cross-functional alignment.
• Manage document review, content governance, and regulatory compliance activities.
• Develop and execute communication, transition and implementation plans for new procedures.
• Design and deliver training programs and learning solutions with required training records.
• Monitor process efficiency and support audit readiness and CAPA planning.

Connaissances

Procedural writing

Regulatory knowledge

GVP knowledge

Clinical trial processes

Stakeholder management

Change management

Cross-functional collaboration

Audit readiness

Analytical thinking

Problem solving

Formation

Bachelor’s degree with 8+ years experience

Master’s degree with 3-4 years experience

Outils

Clinical Trial Management

Regulatory Affairs

Pharmacovigilance

Risk Management

Description du poste

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 to join our Global Development Process & Procedures team, supporting global development in a hybrid work model. In this role, you will lead the development, revision, implementation, and continuous improvement of procedural documents that support clinical trial delivery while collaborating with subject matter experts, functional leaders, project teams, and training partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where: Remote UK or Remote Ireland. Occasional travel needed for team building purposes.

Discover your role

• Lead the development, revision, approval, and implementation of procedural documents that support global development processes.
• Partner with subject matter experts and functional teams to drive process improvements, change management activities, and cross-functional alignment.
• Manage document review, content governance, and compliance activities to ensure alignment with regulatory requirements.
• Develop and execute communication, transition and implementation plans that enable successful adoption of new and updated procedures.
• Design and deliver training programs, performance support tools, and learning solutions while maintaining associated training requirements and records.
• Monitor process efficiency, support audit and inspection readiness activities, and contribute to corrective and preventive action planning.

Requirements

• Bachelor’s degree with 8+ years of relevant industry experience or Master’s degree with 3-4 years of relevant industry experience, coupled with strong procedural writing experience within the pharmaceutical industry and knowledge of Good Pharmacovigilance Practice (GVP) and regulatory requirements.
• Experience supporting global clinical trial processes, developing and improving procedures, and translating operational needs into effective process, training, and procedural solutions.
• Familiarity with Clinical Trial Management, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Risk Management, audits, inspections, and corrective and preventive action planning.
• Proven ability to manage multiple priorities and projects in a matrix environment, optimize resources, and influence stakeholders across functions and organizational levels.
• Strong analytical, critical thinking, problem-solving, negotiation, communication, and stakeholder management skills, with a high degree of integrity, emotional intelligence, attention to detail, and customer focus.
• Ability to work independently and collaboratively in cross-functional teams; Six Sigma or process improvement expertise is preferred.

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.

Salary Range (annually) €86,800.00 - €141,200.00

Total Rewards Package

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
• 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/.

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.

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.