Senior Manager Process & Procedures Operations GVP

Regeneron Pharmaceuticals, Inc.; Ireland; A distancia; EUR 120.000 - 160.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager to lead the development and governance of procedural documents that support global development and clinical trial delivery.

This role collaborates with subject matter experts, functional leaders, and training partners to drive change and ensure regulatory compliance. You will design training, manage cross-functional programs, and monitor process efficiency while supporting audit readiness and CAPA activities across a hybrid, remote

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Procedural writing

Process improvement

Stakeholder management

Analytical thinking

Communication

Six Sigma

Cross-functional

Project management

Educación

Bachelor's degree

Master's degree

Descripción del empleo

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.

This role requires:

• 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.

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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required