Staff CMC Global Submissions Specialist

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Job description

Regeneron is currently looking for a Staff CMC Regulatory Sciences Specialist for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory professional responsible for overseeing CMC aspects of global submissions. This position would focus on initial commercial applications, completing the CMC aspects (e.g., Module 3) of submission content.

As a Staff CMC Regulatory Sciences Specialist. 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 non-US/EU 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 non-US/EU markets.

• Monitor regulatory trends, changes, and agency feedback in non-US/EU 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 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 non-US/EU markets global submissions

• Strong knowledge of CMC regulatory requirements and guidelines in non-US/EU 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 and

• 8 years of experience within biopharmaceutical equipment, manufacturing and/or CMC regulatory industry or equivalent combination of education and experience.

• 10 years of experience within biopharmaceutical equipment, manufacturing and/or CMC regulatory industry or equivalent combination of education and experience.

• Advanced degree preferred (MS or PhD).

• 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 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

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