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Manager, CMC Regulatory Sciences - Global Submissions

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
May 7, 2024

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Job Details

Regeneron is currently looking for a Manager for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory professional responsible for overseeing CMC aspects of global submissions, with a particular focus on rest of world (ROW, ex-US/EU) initial marketing applications.

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

  • Develop processes and tools for the preparation of global marketing applications.

  • Support the development and execution of CMC regulatory strategies for global markets.

  • Lead the preparation, coordination, and compilation of CMC regulatory submissions for ROW markets in accordance with local regulations and guidelines.

  • Develop and maintain relationships with cross functional teams, contract manufacturing organizations, as well as global regulatory partners.

  • Participates in and leads cross-functional and team meetings related to program submission strategies (timelines, approach, deliverables).

  • Provide regulatory guidance and expertise to internal teams regarding CMC requirements and updates for ROW markets.

  • Monitor regulatory trends, changes, and agency feedback in ROW markets to keep the relevant submission planning tools and processes up to date.

  • Assists with the timely and accurate assembly of responses to inquiries from regulatory agencies on the content of CMC documents.

  • Provides direction to CMC RS Specialists to support activities related to the finalization of CMC documents in accordance with established timelines.

  • When applicable, interacts with regulatory authorities from international health agencies in support of the CMC modules of regulatory submissions.

  • Keeps all stakeholders, including external partners, informed of progress and escalates risks (and mitigation options), as necessary.

This role may be for you if:

  • Experience in managing rest of world (ROW) global submissions

  • Strong knowledge of CMC regulatory requirements and guidelines in ROW markets

  • Excellent written and verbal communication skills

  • The ability to work cross-functionally and manage multiple projects simultaneously,

  • Proficiency in Microsoft Office Suite and regulatory information management systems.

In order to be considered for this position, you must hold a BS/BA degree in a scientific discipline, with relevant experience or equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.

  • Associate Manager: Requires 6+ years of relevant experience

  • Manager: Requires 7+ years of relevant experience

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)

$89,100.00 - $170,100.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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