We are currently looking to fill a Senior Manager, CMC Regulatory Sciences position. The Senior Manager of the Program Independent Regulatory Sciences group will lead a new team responsible for preparing all types of CMC sections of marketing authorization applications (BLA/MAA), Clinical trial applications (CTA/IND), post-approval submissions, and regulatory agency interactions. This role will provide leadership and guidance to a team of people supporting regulatory agency interactions and will provide regulatory expertise and out-of-the-box problem solving to all areas of Regeneron’s Industrial Operations and Product Supply organization. The team will support the entire product portfolio and this role will work closely with program-dedicated team management to identify where resources are needed and assign specialists to projects according to business priorities. This role will provide technical guidance and vision for the introduction of new technologies into the CMC Regulatory Sciences submissions space and will work collaboratively with product-focused teams to develop regulatory strategies and mitigate risks to filings through open and transparent communication
In this role, a typical day might include the following:
- Manage activities of assigned regulatory sciences team, including one or more managerial staff
- Oversee assignment of regulatory sciences program independent staff to regulatory project teams across Regeneron’s product portfolio, in alignment with company priorities
- Oversee highly experienced regulatory sciences staff providing technical and regulatory expertise for all types of regulatory submissions
- Oversee improvement efforts based on trends, new regulations/guidances, agency feedback and interactions, industry forums, etc
- Lead and mentor direct reports and junior staff members
- Work with all areas of the business, from early development to commercialization, and apply knowledge of clinical and commercial submission requirements to advance Regeneron’s technologies in the regulatory sciences space
This role may be for you if you:
- good understanding of current CMC-relevant regulations and guidances.
- A proven track record of supporting biological products through development and approval
- Experience managing and developing staff members, particularly experience managing and developing other supervisors/people leaders
- Experience in interacting with FDA and other regulatory authorities
- Strong communication and negotiation skills
- Demonstrated experience building collaboration and partnership across cross-functional teams
- Demonstrated skill in managing multiple priorities
- Strong technical skills and understanding of biopharmaceutical manufacturing process and controls
- BS + 8 years experience, minimum of 5 years of relevant regulatory CMC experience, and at least 3 years of supervisory experience
To be considered for this role you must hold: A BS + 8 years’ experience, minimum of 5 years of relevant regulatory CMC experience, and at least 3 years of supervisory experience
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.