CMC Regulatory Sciences Coordinator- Distribution Compliance

Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: May 14, 2022

Job Description:

We are currently looking to fill a Compliance Coordinator (CMC Regulatory Sciences Distribution Compliance) position. This position executes activities in support of the regulatory aspects of distribution compliance within the CMC Regulatory Sciences Department. We are looking for someone who can efficiently organize and review regulatory documentation and perform reviews to drive clinical and commercial product distribution.In this role, a typical day might include the following:

• Supporting drug supply distribution compliance (beyond GMP compliance) with all aspects of global regulatory filings to ensure stable supply positioning
• Collaborating with various functions to support clinical and commercial regulatory release process and inventory review
• Maintaining tools used to support compliance review of performed batch records against approved regulatory submission
• Maintaining reporting tools to communicate regulatory distribution compliance status to the business
• Keeps management and other cross-functional team members informed on the status of deliverables
• Coordinates the receipt of deliverables from cross-functional areas in a timely mannerThis role might be for you if:
  • You have strong written, verbal, and interpersonal communication skills
  • You can work independently and coordinate multiple projects simultaneously
  • You have strong organizational skills with attention to detailTo be considered for this role, you must have a minimum of an Associate's degree preferably in a scientific field with 2 years of relevant experience or equivalent combination of education and experience. We need someone who can positively support the team through execution of work at a high level and attention to detail.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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.

Keywords: Regeneron Pharmaceuticals, Inc., Troy , CMC Regulatory Sciences Coordinator- Distribution Compliance, Other , Troy, New York