Manager CMC/CP Regulatory Affairs

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  • Company Name Regeneron Pharmaceuticals

Job Description

Job title: Manager CMC/CP Regulatory Affairs

Company: Regeneron Pharmaceuticals

Job description: The candidate will support the development and execution of regulatory strategies for biologic products and combination products for the portfolio assigned and perform the duties outlined belowIn this role, a typical day might include the following:

  • Support CMC/Combination product development activities from a regulatory standpoint during early phase, development, submissions and post market requirements
  • Participate in IOPS cross-functional meetings for program-specific discussions, connect the dots across IOPS, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate or fix them, translates ambiguity into actional steps. Ensure appropriate communications between IOPS and global RA in a timely manner
  • Review the content and format of regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements, scientific advice) to ensure compliance with applicable regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics
  • Participate in global RA meetings and help to develop regulatory strategies to support CMC/CP activities. Participation in communications between Global RA and IOPS as needed

This role may be for you if have:

  • Need to have good understanding of current CMC RA worldwide regulations
  • Experience in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for biologic products / combination products
  • Experience in dealings with FDA and other regulatory authorities is an advantage

To be considered for this opportunity we are looking for:

  • Bachelor’s degree in a relevant technical, scientific field required; advanced degree is an advantage
  • A minimum of 6 years (BS/BA) or 4 years (advanced degree) pharmaceutical/biotech proven experience including a 2 – 4 years of relevant CMC experience

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) $104,300.00 – $170,100.00

Expected salary: $104300 – 170100 per year

Location: USA

Job date: Fri, 29 Mar 2024 07:04:29 GMT

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