Associate Compliance Specialist

We are currently looking to fill an Associate Compliance Specialist position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Compliance Specialists lead compliance related activities, such as investigations, change controls, CAPA, etc. across all areas within the Warehouse & Logistics department.

In this role, a typical day might include the following:

• Leads and handles Change Controls for Warehouse & Logistics

• Ensures that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements

• Leads and participates directly in the investigation process

• Writes and/or reviews investigation reports

• Ensures Corrective & Preventative Actions are appropriate, are implemented as planned and have the intended efficiency

• Identifies recurring events and ensures appropriate actions are taken, such as Management notification

• Keeps team members advised of the status of assigned work

• Works with the team to develop robust training programs

• Provides coordination support during regulatory inspections and partner audits

• Participates in inspection readiness activities

• Writes and edits Warehouse & Logistics standard operating procedures ensuring all documents are in compliance with regulatory requirements

This role might be for you if you:

• Have experience leading investigations/change controls in a cGMP environment

• Can prioritize multiple assignments and changing priorities in a fast-paced environment

• You are organized and have an attention to detail

• You excel in a collaborative, cross functional environment

To be considered for this role you must hold a Bachelors degree and the following minimum amounts of relevant experience for each level:

• Associate Specialist 0-2+ years

• Specialist 2-5+ years

May substitute relevant experience in lieu of educational requirements. Level is determined based on qualifications relevant to the role.

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.

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)