Support CMC development activities from a regulatory standpoint during early phase, development, submissions and post market requirements for gene therapies.
A typical day might include the following:
Participate in cross-functional meetings for program-specific discussions, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate risks
Review the content and format of regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements, scientific advice) to ensure compliance with applicable regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics.
Participate in discussions to develop regulatory strategies to support CMC/CP product development activities.
Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings in accordance with country specific regulatory guidance documents. Demonstrate efficient handling of compliance tasks. Assist specialists and colleagues in regulatory assessment of compliance tasks
Support preparations for interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).
Develop and create Working Instructions, SOPs, and/or Reviewers Guide to facilitate consistent and efficient practice across the CMC RA units.
This role might be for you if you have:
Strong understanding of current CMC RA worldwide regulations.
Familiarity with molecular biology techniques related to gene therapy, RNAi, or oligonucleotide products.
Proven track record of supporting gene therapy, oligonucleotide, or RNAi products through development and approval is a distinct advantage.
Experience in dealings with FDA and other regulatory authorities.
To be considered for this opportunity, you must have at minimum a Bachelors degree in a relevant technical, scientific discipline with a minimum of 5-6 years pharmaceutical/biotech proven 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)
$104,300.00 - $170,100.00