Associate Director Training Lead
3 weeks ago
We are seeking an experienced Associate Director to join our team at Regeneron Ireland DAC. As an Associate Director in GPS Standards & Training, you will play a critical role in maintaining the Pharmacovigilance (PV) Quality Management System.
Key Responsibilities:- Develop and maintain the PV Quality Management System in collaboration with subject matter authorities.
- Coordinate the assignment of adverse event (AE) & product complaint (PC) training globally to vendors.
- Monitor compliance with required training and address non-compliance by working with line management.
- Maintain the AE-PC contract language and liaise with Legal, Procurement, and Commercial as needed to support contract review/update.
- At least 7+ years of experience in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry.
- Bachelor's degree required.
- Previous extensive knowledge and experience within Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
- Consistent record of successful project management related to quality management.
We have an inclusive and diverse culture that provides comprehensive benefits, including 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.
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