Associate Director Good Pharmacovigilance Practice Audits (GVP)

At Regeneron, we are dedicated to transforming lives through innovative medicines and empowering healthcare. We are looking for an outstanding Associate Director, Good Pharmacovigilance Practice (GVP) Audits to join our Global Development Quality Assurance (GDQA) team. This pivotal role offers the opportunity to lead and supervise GVP audits across all aspects of the Regeneron Pharmacovigilance System. As a key member of GDQA, you will play a vital role in ensuring compliance, driving innovation, and mentoring top talent in the field.  

A Typical Day in This Role: 

• Lead risk-based quality auditing activities, ensuring alignment with international regulations and internal requirements. 

• Oversee the execution of GVP audits, including scheduling, preparing, conducting, reporting, and follow-up. 

• Develop and implement new audit standards and methods to stay ahead of technological advancements in global development. 

• Provide guidance and mentorship to audit teams, encouraging professional growth and excellence. 

• Manage GDQA resources effectively to meet annual audit schedules and priorities. 

• Conduct training sessions for GDQA personnel and relevant departments, improving organizational knowledge and skills.

 

This Role May Be For You If: 

• You have a deep understanding of EU and FDA Pharmacovigilance regulations, ICH guidance documents, and other relevant compliance standards. 

• You thrive in dynamic environments and excel at managing multiple high-priority tasks with urgency and precision. 

• You are a strong leader with experience mentoring teams and interfacing with senior/executive leaders. 

• You possess exceptional problem-solving skills and can navigate complex situations with critical thinking and strategic insight.

 

To Be Considered: 

Candidates should possess a bachelor's degree and have at least 11 years of relevant proven experience, including 9+ years of direct GVP auditing and/or industry experience. Strong communication skills and a proven track record in audit and project management are essential. Experience with EU or other regulatory inspections is desirable. Preferred candidates will show talent in stakeholder management, teamwork, critical thinking, and negotiation of complex situations. 

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.