Senior Manager CMC Regulatory Affairs
Senior Manager CMC Regulatory Affairs
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$ 132400 - 216000
1 Vacancy
Job Description
The successful candidate will be responsible for developing and executing regulatory strategies for biologic products including cell and gene therapy product portfolios assigned.
A typical day may include the following:
Responsible for CMC product development activities from a regulatory standpoint during early phase development submissions and post market requirements for Cell and Gene therapies
Provide regulatory interpretation position and strategy for global CMC/CP regulatory portfolios covering early phase development initial registrations and approval/post approval activities
Proactively identify program issues and develop appropriate regulatory strategies to mitigate risks
Critically review and provide strategy input on regulatory filing documents (e.g. preINDs INDs IMPDs BLAs MAAs BPDRs annual reports DSURs amendments supplements scientific advices) to facilitate and expedite the development licensure and marketing of CGT programs.
Lead and facilitate activities including team preparation for meetings with FDA EMAand other regulatory authorities for CMC product development/commercial activitie for CGTs.
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.
This role may be for you if:
Have good understanding of current CMC RA worldwide regulations for advanced therapy medicinal products.
Proven track record of supporting biological products/ advanced therapies through development and approval is a distinct advantage
Experience in delivering CMC sections of marketing authorizations clinical trial applications (CTA/IND) and postapproval submissions for biologic products / combination products particularly advanced therapies
Expertise in gene therapies is an advantage
Experience in dealings with FDA EMA and other regulatory authorities is an advantage
To be considered for this role you must have a minimum of 8 years (BS/BA) pharmaceutical/biotech industry experience including a minimum of 5 years of relevant CMC 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 Companys 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)
Required Experience:
Senior Manager
Employment Type
Full-Time
