Under the leadership and direction of the Director, the Manager LCoE Curricula & Compliance will work with Training Business Partners, managers & SMEs across the R&D organization to understand training compliance business needs and propose system solutions that comply with GxP requirements in a global context.

Typically the Manager will support assignment of new & revised training assets to function-role specific curricula and/or clinical study team role specific curricula, ensuring the right people receive the right training at the right time to be GxP compliant.

In addition to deploying training through the Compliance Wire® learning management system (LMS), the manager will leverage a variety of tools to analyse training compliance trends, derive insights, and enhance curricula and role based assignments in support of GxP compliance.

A typical day in day in this role looks like:

Strategic Alignment:

• Support the build out and ongoing maintenance of LMS data structures to support GxP Global Training, ensuring the training system is audit & inspection ready at all times.

Relationship Management

• Liaise with LCoE extended team including Training Business Partners and Regional Trainers to provide guidance on GxP training curricula needs.
• Partner with LCoE team members to support compliance improvement at global & local levels.

Consulting

• Skilfully apply systems knowledge and tools, to analyze complex LMS data issues and propose optimized solutions.
• Provide guidance to internal customer groups, ensuring compliance in training requirements and documentation & effectiveness in supporting processes.
• Support regulatory audits and inspections through preparing training reports and retrieving key training records & documents.
• Navigate GxP source document vaults to ensure alignment of training assets & assignments and work with document owners to ensure timely, accurate & comprehensive assignments. .

Curricula Support

• Work with stakeholders and the wider LCoE team to establish & maintain role based curricula and usergroup assignments.
• Support activities to review & enhance curricula compliance by function & by country, using system reports to inform curricula & usergroup modifications.

Creativity, Innovation & Problem Solving

• Participate in cross-functional continuous improvement projects related to quality & compliance to ensure learner’s needs are met with appropriate training through streamlined training operations and overall user support efficiency.
• Support LCoE leadership in the implementation plan for improving compliance across supported stakeholder groups globally.

Measurement & Reporting

• Track trends and monitor training compliance; prepare routine progress reports on job specific training programs for Training Business Partners and Regional Trainers.

Training Delivery

• Occasionally prepare presentations & supplementary content to educate or inform stakeholders.

This role may be for you if you have:

• Ability to work both independently and collaboratively as part of a globally distributed remote team.
• High level of proficiency in working with a Learning Management System (Compliance Wire preferable) with experience in working with source document management systems such as Veeva a distinct advantage.
• Detail orientated in data entry tasks, understanding the significance of data discrepancies and when found, able to trouble shoot & apply an appropriate GxP compliant fix
• Knowledge of GxP regulations pertaining to training & quality management systems.
• High level of proficiency in working with MS Tools, especially Excel and Share Point and the ability to use integrated AI tools (e.g., Microsoft 365 Copilot) is a plus
• Critical thinking & problem solving – having exposure to and training in lean six sigma or similar methodology is an advantage
• Experience in managing multiple projects at the same time, with an ability to agree priorities & deliver to target dates
• Clear communication skills, both in person and in writing
• Experience of working with global training teams is preferred
• May require up to 20% travel

In order to be considered qualified for the role a minimum of a bachelors Degree with 7+ years of relevant experience, ideally 3+ years Clinical, Pharmaceutical or Medical Device experience with understanding of GxP guidelines as they relate to training; or 5+ years working in a customer facing role, ideally with an agency or group providing services to the Pharma/Medical Device industry.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$114,800.00 - $187,400.00