CMC Regulatory Sciences Specialist-Post Approval Commercial Submission

Location
Rensselaer, NY, United States
Posted
Oct 12, 2020
Ref
20902BR
Required Education
Bachelors Degree
Position Type
Full time
Summary: 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.

Essential Duties and Responsibilities may include, but are not limited to, 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.
• Manages 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 external partners, informed 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.
• May review relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.
• May proactively identify issues and contributes to the development of appropriate strategies to mitigate risk.
• May assist in preparation for meetings with global regulatory authorities.
• May contribute to developing CMC regulatory strategy.
• May review regulatory submission documents to ensure that all submissions are complete, accurate and meet relevant requirements.
• May oversee and assign projects to other specialists; may have direct reports.

Education and Experience:
• Associate Specialist: BA/BS degree required, preferably in a scientific related field. 0-2 years of relevant experience.
• Specialist: BA/BS degree required, preferably in a scientific related field. 2+ years of relevant experience.
• Senior Specialist: BA/BS degree required, preferably in a scientific related field; advanced degree preferred. 5+ years of relevant experience with BA/BS, 4+ years of relevant experience with advanced degree.

Knowledge and Skills:
• Excellent written and verbal communication skills.
• Ability to work independently, prioritize, coordinate, and complete multiple projects within deadline while maintaining a high level of attention to detail is a must.
• Knowledge of relevant 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 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.