Regeneron is looking for a Compliance Specialist to join our Process Sciences Change Management team. This is a non-lab based position. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality products, done in part through controls applied to our production processes. This position will be responsible for supporting the Process Sciences, Manufacturing, and CMC Regulatory Departments through compliance activities and documentation related to implementation and maintenance of in-process control programs for manufacturing bioprocesses. In this fast-paced environment with a strong pipeline, our Associate Compliance Specialists have an opportunity to work on countless aspects of the process and business.
As s Compliance Specialist- Process Sciences, a typical day might include the following:
- Compiling and organizing information, preparing documentation, evaluating risks, and providing justifications for implementing or updating IPC Programs throughout the Change Management Process.
- Completing and/or reviewing IPC documentation associated with batch manufacture.
- Reviewing technical documents and reports for content, formatting, and data consistency prior to document approval.
- Coordinating with stakeholders to obtain data and statistically analyzing the data received in order to write technical reports to support updates and changes to the IPC programs.
- Presenting on compliance topics to senior leadership and during cross functional meetings.
- Participating in brainstorming sessions where we look for ways to improve our development and compliance processes.
- Assisting in troubleshooting and providing compliance support to the IPC Development Team as needed.
This role might be for you if you:
- Enjoy working in a fast-paced environment.
- Are detail oriented, quality driven and well organized.
- Have the innate ability to balance multiple projects, prioritize them and execute them independently, while excelling at keeping all impacted parties well advised.
- Can take on new and sometimes ambiguous challenges, learning quickly.
- Enjoy working in a team environment but can also take ownership of multi-faceted projects and technical reports.
- Can develop and drive scientific and/or business-related improvement ideas.
- Understand antibody manufacturing processes.
- Have a solid understanding of Microsoft Suite (Word, Excel, Powerpoint).
To be considered for the Compliance Specialist – Process Sciences position, you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a Bachelors in life sciences/engineering or related field; Chemical Engineering or Biochemistry preferred, as is a practical understanding of statistical methods.
- Associate Compliance Specialist: 0-2 years of relevant experience
- Compliance Specialist 2+ years of relevant experience
- Sr. Compliance Specialist 5+ years of relevant experience
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)
$58,480.40 - $124,300.00
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At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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