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Manager CMC Regulatory Sciences, Clinical

Job Description

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The Manager, CMC Regulatory Sciences for Clinical Submissions leads a team that manages the CMC regulatory submission work across multiple clinical programs and/or submissions.

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

  • Managing and developing CMC Regulatory Sciences (CMC RS) staff/direct reports (including contributing to regulatory strategy discussions, project direction, and ensuring alignment between regulatory submissions and product supply plans).
  • Provide management support at cross-functional and team meetings related to program submission strategies (timelines, approach, deliverables), while developing excellent relationships with a variety of functional areas and cross functional teams, contract manufacturing organizations, as well as global regulatory partners.
  • Oversees (in collaboration with writing teams) the completion of CMC RS regulatory submissions, manages workload and provides direction to CMC RS Specialists and/or other CMC RS staff.
  • Helps prepare and/or reviews a variety of CMC regulatory submissions and supporting documents including dossier content (INDs, IMPDss, amendments), meeting requests and briefing books, ensuring that all submissions are complete, accurate, and meet relevant requirements.
  • Assists with the timely and accurate assembly of responses to inquiries from regulatory agencies on the content of CMC documents
  • Collaborates with project teams to support activities related to the finalization of CMC documents in accordance with established timelines, keeping all stakeholders, including external partners when applicable, informed of progress and escalating risks (and mitigation options) as necessary.
  • When applicable, interacts with regulatory authorities from US and international health agencies in support of the CMC modules of regulatory submissions.
  • Reviews and/or approves CMC submission content, ancillary CMC documents and reports for completeness and accuracy and for compliance with regulations.
  • Contributes to the development and execution of CMC regulatory strategies for programs
  • Identifies project issues and contributes to development of alternate strategies.
  • Keeps management informed of decisions, overall strategy and project status.

This role may be for you if you:

  • Have excellent written and verbal communication skills,
  • Strong skills in planning, critical thinking and problem-solving,
  • Are comfortable dealing with shifting priorities and changes in strategy,
  • Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a level of attention to detail,
  • Knowledge of drug development regulations and guidelines (i.e. FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices).

In order to be considered for this position, you must hold bachelors in Chemistry, Biology or related field, and

  • Associate Manager: Requires 6+ years of relevant experience
  • Manager: Requires 7+ years of relevant experience
  • Experience in the pharmaceutical or medical device, including some supervisory and/or leadership experience is preferred
  • May consider experience in lieu of education; level decided upon completion of an interview process

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)

$89,100.00 - $170,100.00