Senior Manager Process & Procedures Operations GVP

About the role

Regeneron is looking for a Senior Manager to join its Global Development Process & Procedures team, supporting global development in a hybrid work model. You will lead the development, revision, implementation and continuous improvement of procedural documents that support clinical trial delivery, working with subject matter experts, functional leaders, project teams and training partners. The position is remote in the UK or Ireland, with occasional travel for team building.

Key responsibilities

• Lead the development, revision, approval and implementation of procedural documents supporting global development processes.
• Partner with subject matter experts and functional teams on process improvements, change management and cross-functional alignment.
• Manage document review, content governance and compliance to align with regulatory requirements.
• Develop and run communication, transition and implementation plans for new and updated procedures.
• Design and deliver training programs, performance support tools and learning solutions, keeping training requirements and records.
• Monitor process efficiency, support audit and inspection readiness and contribute to corrective and preventive action planning.

Required profile

• Bachelor's degree with 8+ years of relevant industry experience, or a Master's degree with 3-4 years, plus strong procedural writing experience in the pharmaceutical industry and knowledge of Good Pharmacovigilance Practice (GVP) and regulatory requirements.
• Experience supporting global clinical trial processes and turning operational needs into process, training and procedural solutions.
• Familiarity with Clinical Trial Management, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Risk Management, audits, inspections and CAPA.
• Proven ability to manage multiple priorities in a matrix environment and influence stakeholders.
• Strong analytical, problem-solving, negotiation and stakeholder management skills, with integrity, attention to detail and customer focus.
• Ability to work independently and collaboratively; Six Sigma or process improvement expertise preferred.

What we offer

• Salary range of EUR 86,800 to EUR 141,200 per year, depending on country, role level and experience.
• Possible annual bonuses, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, insurance benefits, paid time off and family support benefits.