CMC Regulatory Sciences Specialist
- Regeneron Pharmaceuticals, Inc.
- Troy, New York
- Start date
- Mar 17, 2023
- Clinical, Clinical Medicine, Science/R&D, CMC
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
We are currently looking to fill a CMC Regulatory Sciences Specialist position, this position is responsible for providing Chemistry, Manufacturing, and Controls (CMC) support across Regeneron’s sites. Routine activities include dossier development for clinical trial applications, marketing applications, amendments, post approval variations and other regulatory submissions.
In this role, a typical day might include the following:
- Prepares global CMC documents and sections for a variety of clinical and commercial biopharmaceutical regulatory submissions, ensuring that all submissions are complete, accurate and meet relevant requirements.
- Handles and coordinates the authoring, review and finalization of CMC documents and responses to CMC-related inquiries from Regulatory agencies, in accordance with submission timelines, keeping all team members, including third-party partners, advised of progress.
- Collaborates and develops excellent relationships with functional area and cross functional teams, contract manufacturing organizations and global Regulatory partners.
- Applies in-depth understanding of regulatory guidance and regulations, as well as industry and government agency standard processes and trends.
- Review relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.
- Proactively identify issues and contributes to the development of appropriate strategies to mitigate risk.
- Assist in preparation for meetings with global regulatory authorities.
- Contribute to developing CMC regulatory strategy.
- Review regulatory submission documents to ensure that all submissions are complete, accurate and meet relevant requirements.
- Coordinate and assign projects to specialists
This role may be for you if you:
- Excellent written and verbal communication skills.
- Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a level of attention to detail.
- Knowledge of drug development regulations and guidelines (i.e. FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices).
- Strong skills in planning, critical thinking and problem-solving.
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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
To be considered for the CMC Regulatory Sciences Specialist role, you must have the following: BA/BS degree required, preferably in a scientific related field.
· Associate CMC Reg Sci Specialist - 0-2+ years
· CMC Reg Sci Specialist - 2+ years
· Sr CMC Reg Sci Specialist - 4+ years
Level is determined based on qualifications relevant to the role.
Salary Range (annually)$55,700.00 - $121,300.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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