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CMC Regulatory Sciences Coordinator

3 months ago

Troy, United States Regeneron Pharmaceuticals Full time

The CMC Regulatory Sciences Coordinator is responsible for coordinating and supporting the deliverables and continuous improvement projects of the CMC Regulatory Sciences department to ensure timelines are met, potential resource constraints are anticipated, and changes in the expectations of regulatory authorities are incorporated into the business.

As a CMC Regulatory Sciences Coordinator, a typical day might include the following:

  • Program tracking:

  • Tracks the due dates for Specialist deliverables to help identify resource constraints before they result in slipping timelines.

  • Coordinates the initiation of regulatory submission document reviews (e.g., cross-functional reviews and copyediting/data verification reviews with the CMC-RS Document Quality group.

  • Provides submission coordination support:

    • Initiates SharePoint workflows.

    • Updates batch analysis tables as new lots are dispositioned.

  • Formats submission sections (e.g., stability and batch analysis tables).

  • With guidance/oversight of specialists, organizes the product SharePoint folders into a consistent scheme with improved navigability.

  • Tracks ex-US commercial filings completed by partners.

  • Creates/maintains content trackers for regulatory submissions for assigned programs.

  • Keeps management and others informed on progress of CMC-RS deliverables for assigned programs.

  • Department support:

  • Prepares agendas and minutes for group and department meetings. Prepares group and department newsletters.

  • Coordinates validation protocol and report reviews.

  • May oversee projects and assign projects to other coordinators.

This role may be for you if:

  • You have excellent written and verbal communication skills.

  • You have the ability to prioritize, coordinate, and complete multiple projects within deadline under minimal supervision, while maintaining a high level of attention to detail is a must.

  • You exhibit strong skills in planning, critical thinking, and problem-solving.

In order to be considered for this position, you must have the following:

  • Requires Associates degree and 2+ years of relevant experience or equivalent combination of education and experience; Bachelors degree preferred.

  • Project management experience preferred.

  • Strong experience creating and maintaining reports, specifically with MS Word and Excel.

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 (hourly)

$23.89 - $42.93