We are currently looking to fill a Manager, CMC Regulatory Sciences position. Responsible for overseeing information collection, distillation and assessment activities associated with the support functions and preparation of CMC regulatory submissions for clinical programs.
In this role, a typical day might include the following:
- Managing and developing CMC-RS staff/direct reports.
- Oversees the completion of CMC-RS projects, manages workload and provides direction to CMC-RS Specialists and/or other CMC-RS staff.
- Coordinates or assists with the preparation of a variety of CMC documents.
- Collaborates with project teams to manage and coordinate activities related to the finalization of CMC documents in accordance with established timelines, keeping all stakeholders, including external partners when applicable, informed of progress.
- When applicable, interacts with regulatory authorities from US and international health agencies in support of the CMC modules of regulatory submissions.
- Assists with the timely and accurate assembly of responses to inquiries from Regulatory agencies on the content of CMC documents, when applicable.
- Reviews ancillary CMC documents and reports for completeness and accuracy and for compliance with regulations.
- Identifies project issues and contributes to development of alternate CMC Regulatory Sciences strategies.
- Keeps management informed of decisions, overall strategy and project status.
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.
To be considered for this role you must hold: Requires BS/BA degree in Chemistry, Biology or related field, with relevant experience or equivalent combination of education and experience, preferably pharmaceutical or medical device, including some supervisory and/or leadership experience.
- Associate Manager: Requires 6+ years of relevant experience
- Manager – Requires 8+ Years of relevant experience
Level is determined based on qualifications relevant to the role.
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 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.