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Regulatory Affairs Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, NY, United States
Start date
Apr 29, 2019

View more

Discipline
Clinical, Clinical Medicine, Regulatory
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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

• Contribute to development of best practice user guides

Requirements:

Education

• Degree in life sciences. PharmD, PhD, OR MD REQUIRED 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.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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