We are currently looking to fill a CMC Regulatory Sciences Manager (Pre Approval Commercial Programs) position. This role provides regulatory support across Regeneron’s sites. They assist through dossier strategy development for initial commercial marketing applications
In this role, a typical day might include the following:
- Overseeing commercial submission readiness planning and strategies for one or more programs in development
- Developing staff and direct reports in pre-approval space and coordinating and assigning projects to specialists
- Collaborating and developing excellent relationships with functional area and cross functional teams, contract manufacturing organizations, and global regulatory partners.
- Applying in-depth understanding of global regulatory guidance and regulations, as well as industry and government agency standard methodologies and trends.
- Reviewing relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.
- Overseeing the authoring, review, and finalization of CMC documents and responses to CMC-related inquiries from regulatory agencies.
- Overseeing the preparation of CMC documents and sections for a variety of commercial biopharmaceutical regulatory submissions, ensuring that all submissions are complete, accurate, and meet relevant requirements.
- When applicable, interacting with regulatory authorities from US and international health authorities in support of the CMC modules of regulatory submissions.
This role may be for you if you:
- You possess 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).
- You proactively identify issues and contribute to the development of appropriate strategies to mitigate risk.
- You want to contribute to developing CMC regulatory strategy.
- You want to develop a team of skilled pre-approval specialists.
- You exhibit excellent written and verbal communication skills.
- You want to use your strong skills in planning, critical thinking, and problem-solving.
- You can work independently, prioritize, coordinate, and monitor multiple projects within deadlines while maintaining a high level of attention to detail.
To be considered for this role you must hold: 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 7+ 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.