Head of Regulatory Affairs CMC

Rensselaer, New York, United States of America
Jul 08, 2021
Required Education
Bachelors Degree
Position Type
Full time
This position leads the Global CMC Regulatory team), negotiates the Global CMC Regulatory strategy with the EVP of Industrial Operations and Product Supply (IOPS) and is responsible for executing against that strategy, including quality and timeliness of all of REGN's CMC submissions worldwide. The primary purpose of this role is to partner with IOPS to identify how to meet Regeneron's objectives including all of the worldwide regulatory submission timelines while maintaining all regulatory compliance and safety regulations. In addition, this person will serve as a trusted advisor to senior management regarding CMC Regulatory strategies/processes and provides independent assessments of process changes that may impact the regulatory approval timelines and/product safety. In partnership with IOPS, identifies multiple options to decide on the optimal path to regulatory approval for each indication.

As Head of CMC Regulatory Affairs, a typical day might include:Executing of all worldwide regulatory strategies for CMC process development, validation, and for post-approval/post-validation changes to ensure Regulatory Agency approval(s) within specified timelines and supply chain for marketed products and for clinical studiesDevising CMC regulatory strategies with IOPS management to support the IOPS function through understanding regulatory process and proactively plan and negotiate to achieve their business objectives with the regulators. Ensuring the team completes risk mitigation plans for unexpected outcomes of interactions with health authorities.Supporting the IOPS function to manage worldwide approvals for changes to commercial or clinical manufacturing and translate the process change implications through country specific assessments.Overseeing Regulatory CMC liaisons with their project specific communications, including Agency meetings and provide leadership and support for all CMC focused regulatory agency meetings
This role might be for you if:You are a natural collaborator who enjoys working on a cross-functional teams.You are an outstanding communicator in all forums. You have a demonstrated ability to influence peers and senior leaders using data, while being open to listening and learning from others.You can foster a collaborative, innovative, problem solving culture and mind-set.
To be considered for this position you must have an advanced degree in a science related field. Cell and biological education preferred. A minimum of 15 years of pharmaceutical industry or related experience, at least 10 years of which includes applicable managerial Regulatory experience in CMC related activities for biologicals, monoclonal antibodies or other large molecule therapeutics. Previous experience leading a CMC function that was responsible for multiple products across all phases of drug development is required. Prior research laboratory, process development or manufacturing experience with biotechnology products is strongly preferred.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.