Sr Compliance Specialist
- Regeneron Pharmaceuticals, Inc.
- East Greenbush, New York
- Start date
- Mar 23, 2023
- Clinical, Clinical Medicine, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
We are currently looking to fill a Compliance Specialist (Warehouse & Logistics) 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 Bachelor’s degree and the following minimum amounts of relevant experience for each level:
- Associate Specialist – 0-2+ years
- Specialist – 2-5+ years
- Sr Specialist – 5+ years
May substitute relevant experience in lieu of educational requirements. Level is determined based on qualifications relevant to the role.Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)$55,700.00 - $121,300.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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