Associate Manager, Regulatory Liaison

Location
Tarrytown, New York, US
Posted
Dec 07, 2018
Ref
13202BR
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 . This position in Regulatory Affairs involves the ability to support and provide some management for the operations governing pharmaceutical drug development to all aspects of Regeneron's quality, preclinical and clinical drug development programs, policies, and procedures meeting the necessary state of compliance relative to all regulatory commitments . JOB RESPONSIBILITIES . Assist in managing the preparation, compilation, and organization of regulatory submissions including INDs, BLAs, MAAs, annual reports, IND amendments, BLA supplements, and MAA variations in accordance with title 21 CFR and all FDA, EU and ICH guidelines . Ensure the timely submission of above consistent with US FDA and other country regulatory requirements . Perform quality control review of regulatory documents for accuracy, completeness, and conformance to appropriate regulations, guidelines, and SOPs . Participate in cross-functional departmental team projects and product development activities/meetings . Provide department SOP training and compliance, including writing project specific SOPs . Manage regulatory communications, including drafting of letters based on templates . Coordinate the drafting of labeling documents and serve as technical labeling writer . Manage library of references for use in regulatory submissions. JOB REQUIREMENTS . Education . Bachelors Degree in life science related discipline. Experience . 6 years of 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.