Manager CMC Regulatory Affairs

Location
Rensselaer, New York, US
Posted
May 17, 2018
Ref
13086BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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: Acts as the CMC Regulatory Affairs lead for a subset of programs to guide the Industrial Operations and Product Supply (lOPS) team in the decision-making process and strategic planning on the regulatory aspect.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Plans and conducts critical reviews of and track and/or complete CMC regulatory commitments for pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, and supplements to ensure a high quality regulatory submission and approval.
• As a member of the CMC Regulatory Affairs management team, leads the preparation of meeting requests, briefing books, and responses to information requests received from various Health agencies.
• Review Change Controls, NOE's, EOE's, and DNF's by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and ensures that CMC related changes are reported to competent authorities in accordance with regulatory requirements, as necessary.
• Reviews all deviations and provides regulatory assessments to support manufacturing operation.
• Provides CMC-related guidance to manufacturing organization so that their short-term and long-term goals are achieved on time and with highest quality.
• Leads or participates in CMC project team meetings and provides current regulatory requirements that pertain to stability studies and analytical characterization tests.
• Monitors related corporate activities for regulatory compliance to support manufacturing.
• Identifies priorities and key issues in complex situations and solves these problems.

Knowledge and Skills:
• Ability to establish sound working relationships, both internally and with outside organizations.
• Detail and deadline oriented; well organized.
• Excellent verbal and written communication skills.
• Computer proficiency a must; ability to work on all types of electronic systems including document management systems.
• Good interpersonal skills; ability to interact with peers at all levels.
• Project management experience is highly desirable.
• Demonstrated ability to plan, organize, and prioritize tasks; to work simultaneously on multiple projects according to timelines.

Education and Experience:
• BS/BA required; advanced degree preferred, in life sciences or related field
• Minimum of 7 years of related experience in CMC regulatory, and/or process/analytical science in bio/pharmaceutical industry required

* Title level (Associate Manager, Manager, or Senior Manager) will be determined based on skills and 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.

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Requisition Number: 13086BR