CMC Regulatory Sciences Specialist
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 stakeholders, 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 best practices 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
- 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.
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 Specialist level aligns with 0-2 years of relevant experience, Specialist level 2+ years of relevant experience. At the Senior Specialist level an advanced degree is preferred with 4+ years of relevant experience or 5+ years of relevant experience with BA/BS. Level is determined based on qualifications relevant to the role. Regulatory experience is a plus.
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.