Associate Director Regulatory Compliance
2 weeks ago
As an Associate Director, GPS Quality and Compliance a typical day might include the following:
Developing and implementing compliance and quality oversight governance for GPS Safety Sciences deliverables, including Risk Management Plans, Signal Management, and the Pharmacovigilance System Master File.
Establishing and refining key performance indicators to ensure overall quality and compliance.
Collaborating closely with GPS subject matter experts, Regulatory Affairs, Medical Affairs, and other key functions to proactively identify potential trends or significant non-compliance.
Conducting non-compliance investigations for minor events, supporting investigation, and CAPA implementation of significant quality events.
Providing support for quality reviews of additional GPS deliverables, including Safety Agreements and Safety Management Plans.
Supporting GPS-related audits and inspections.
Proven track record to prioritize tasks effectively and manage multiple projects simultaneously.
To be considered for this opportunity, you must have a minimum of a Bachelor's Degree and 10 years of pharmacovigilance-related experience; You should possess strong digital literacy, particularly with Microsoft programs (Word, Excel, PowerPoint, Outlook), and familiarity with data analytics platforms. A solid understanding of safety databases, medical concepts, and terminology is crucial. Expertise in benefit-risk management and experience in leading job performance. We need someone who will demonstrate success in leading and implementing quality and compliance programs within a global pharmaceutical environment.
We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels
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.
S. law and apply to U.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. 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.
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