Director, CMC Regulatory Affairs

Location
Rensselaer, NY, United States
Posted
Jan 10, 2019
Ref
15220BR
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:
Maintain active engagement with emerging and current regulatory trends in the industry and act in a consultative capacity to IOPS and clinical regulatory affairs as related decisions and processes are executed. Support all CMC regulatory filing activities for various pre-INDs, INDs, IMPDs, CTAs, BLAs, MAAs and track regulatory commitments. Additonally, evaluate Change Controls and assign regulatory actions as needed

Job Duties:

• Manage timelines in cooperation with project management, IOPS/Tarrytown SMEs and Tarrytown Regulatory Operations (RegOps) to ensure on-time regulatory submissions.

• Assist with the planning, scientific writing and perform critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements to ensure a high quality regulatory submission and approval.

• Ensure that all regulatory submissions are of highest regulatory standard.

• Coordinate and manage regulatory inspections, as needed, at the Raheen site or at other sites if the inspection relates to regulatory CMC issues.

• Assist in review of IOPS change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements.

• Support establishing, managing and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.

• Assist in tracking of CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs.

• Participate, as needed, in planning, organizing and managing the CMC component of pre-IND, pre-BLA and other Type C meetings with the FDA.

• Support IOPS by providing CMC related guidances so that their short-term and long-term goals are achieved on time and with highest quality.

• Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests.

Requirements:

Education and Experience:

• Requires an advanced degree in a science related discipline and a minimum of 15 years pharmaceutical industry experience and 8 years of relevant RA CMC biotech/pharmaceutical industry 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.