Regeneron Pharmaceuticals, Inc
Director, CMC Industry and Regulatory Intelligence
Regeneron Pharmaceuticals, Inc, Troy, New York, United States,
We are currently looking to fill a Senior Manager of CMC Industry and Regulatory Intelligence position. In this role, you would be responsible for enabling chemistry manufacturing and controls (CMC) quality and compliance excellence by ensuring Regeneron IOPS maintains effective systems for monitoring, analyzing, communicating, and implementing global regulatory and industry trends, regulations, and pharmacopoeia. You will also be encouraged to develop and implement strategies to translate CMC intelligence gathering into action for all CMC operations across Regeneron.
As a Senior Manager of CMC Industry and Regulatory Intelligence, a typical day might include the following:
Provides oversight on the IOPS CMC intelligence program.
Collaborates with the Regulatory Intelligence and GMP Compliance and Inspections teams to support and drive activities that ensure appropriate regulatory intelligence and compliance information is maintained and made available throughout IOPS.
Monitors and assesses all sources of global CMC intelligence information, including industry trends, for relevance and impact to internal processes, drug development projects and/or regulatory strategies and ensures that internal procedures are introduced or adapted to respond to changes in the regulatory environment.
Develops internal guidance for their area based on the disseminated materials and discussions.
Establishes working groups, facilitates discussions, and leads presentations that examine regulatory intelligence and analysis of emerging trends and risks by bringing together subject matter experts from across all departments and levels to ensure compliance.
Collaborates with subject matter experts to develop and implement strategies to ensure that our products and processes are aligned with relevant regulations, collaborates with internal and external stakeholders, and provides guidance to teams across the organization.
Contributes to conference presentations, journal publications, and actively participates in appropriate professional bodies and regulatory forums.
This role may be for you if you have:
Experience working in a complex and matrix environment. Strong negotiation skills to reach consensus. Strong communication skills, both oral and written. Strong project management leadership skills essential. Good understanding of the drug development and commercialization process, with a focus on CMC. Experience in understanding and interpreting regulatory guidelines and documents. Ability to research, analyze and extrapolate critical regulatory information. Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization at all levels. To be considered for the Senior Manager level, you must hold a bachelor's degree in life science, preferably related to health, environment or politics, or a related degree, and 12+ years of related experience in a regulated industry or health authority.
Experience can be in lieu of education
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) $122,000.00 - $199,000.00
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This role may be for you if you have:
Experience working in a complex and matrix environment. Strong negotiation skills to reach consensus. Strong communication skills, both oral and written. Strong project management leadership skills essential. Good understanding of the drug development and commercialization process, with a focus on CMC. Experience in understanding and interpreting regulatory guidelines and documents. Ability to research, analyze and extrapolate critical regulatory information. Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization at all levels. To be considered for the Senior Manager level, you must hold a bachelor's degree in life science, preferably related to health, environment or politics, or a related degree, and 12+ years of related experience in a regulated industry or health authority.
Experience can be in lieu of education
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) $122,000.00 - $199,000.00
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