Regulatory Affairs Specialist

Location
Tarrytown, New York, US
Posted
Nov 27, 2018
Ref
14845BR
Required Education
Masters Degree/MBA
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 Regulatory Affairs Specialist supports more senior regulatory liaisons in the management of agency correspondence/submissions and in the tracking of emerging legislation with business impact for Regeneron . Job Duties . Provide hands on support in the preparation, compilation, and organization of regulatory submissions e.g. INDs, BLAs, MAAs, DSURs, IND amendments, BLA supplements, etc . Review and ensure consistency, completeness and adherence to standards for all regulatory submissions and timely submission of above in accordance with title 21 CFR and FDA, EU and ICH guidelines . Manage regulatory submissions for multiple indications . Summarize regulatory guidance, precedence and competitive intelligence to facilitate the development of regulatory strategy . Be proficient in regulatory databases Cortellis, Doctor Evidence, Trial Trove, 1st Oncology, Pharmapendium . Contribute to development of best practice user guides . Requirements . Education . Degree in life sciences. Masters or PhD preferable . Experience and Skills . 2 years of pharmaceutical industry experience . Strong oral and written communication skills . Ability to plan and organize effectively . Attention to detail and follow through . 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.