Regeneron is looking for a Compliance Specialist to join our Process Sciences Change Management team. This is a non-lab-based position. This position will be responsible for supporting the Process Sciences, Manufacturing, and CMC Regulatory departments through the development of strategic plans to support change management activities and documentation related to implementation and maintenance of process control programs for bulk drug substance / formulated drug substance, drug product, combination product, and advanced therapies manufacturing bioprocesses. In this fast-paced environment with a strong pipeline, our Compliance Specialists have an opportunity to work on countless aspects of the process and business.
As a Compliance Specialist, a typical day might include the following:
- Craft business plans to independently advance change control initiatives to implement lifecycle activities of established manufacturing control strategies in support of Global Process Sciences.
- Provides the technical justification to support change management.
- Evaluates the impact of global change controls across the product lifecycle.
- Performs product impact assessments.
- Participates in quality risk assessments.
- Coordinate and/or lead cross-functional discussions in support of Global Process Sciences to drive implementation of changes.
- Coordinates with stakeholders to obtain and analyze data received in order to write technical reports.
- Review, edit, and revise controlled documentation for content, formatting, and data consistency in accordance with cGMP standards.
- Coordinates the exchange of data and other information between Process Sciences, CMC Regulatory, Project Management, and Quality Assurance.
- Independently tracks multiple team projects to ensure that the deliverables within the project plan are met and are on time – identifying, addressing, and/or raising potential obstacles in a timely manner.
- Presents on compliance topics to senior leadership and during cross functional meetings.
- Produces and maintains accurate records.
- May lead special projects, as assigned.
This role might be for you if you:
- Excel in a quality driven organization.
- Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills.
- Have a strong attention to detail.
- Have strong technical writing and interpersonal communication skills.
- Enjoy working in a fast-paced environment.
- Have experience navigating a controlled quality system (preferred but not required).
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. cGMP experience is desirable.
- 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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