Associate Manager / Manager, CMC Regulatory Project Management

Rensselaer, New York, US
Oct 07, 2018
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: The Manager/Associate Manager Regulatory Project Management uses program management knowledge to plan and lead the progress of pharmaceutical regulatory submissions for clinical and commercial programs.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Utilizes program management best practices to ensure programs meet timelines while ensuring quality.

• Serves as primary point of contact among cross-functional areas to facilitate the development and execution of regulatory strategy.

• Collaborates with research and development, manufacturing and regulatory personnel in the preparation and review of regulatory strategy documents; anticipates and identifies potential regulatory risk. Keeps management and others informed on progress of documents/regulatory deliverables.

• Facilitates and leads regulatory strategy communication between global functional areas and corporate partners, including presentations for management and joint collaboration meetings. Consistently maintains professionalism in communication, e.g. maintaining composure under pressure and managing up.

• Leads a team of regulatory project coordinators; capable of mentoring and managing team members through influence rather than direct authority; ensures delegation to appropriate team members based on expertise.

• Ensures workload is prioritized and equitably allocated among direct reports.
Education and Experience:

• BS/BA degree required; advanced degree preferred and at least 4 years of experience with biopharmaceutical equipment or manufacturing, along with at least 1 year leadership/supervisory experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.