Temp - Regulatory Compliance Associate

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:

Responsible for releasing investigational product to countries and sites participating in clinical studies, which includes ensuring completeness, accuracy, and delivery of Regulatory documents to trial master files, and identifying and resolving discrepancies. Also responsible for providing Regulatory compliance support which includes providing assistance with Regulatory Submission and Approval Tracking activities, completing Regulatory checklists, assisting with Regulatory inspection readiness activities, and identifying process gaps and areas for improvements.

Job Duties:

Essential Functions required for the job. List both technical and managerial requirements if applicable.

• Assist with Regulatory Submission and Approval Tracking activities

• Assists in reviewing essential documents to verify regulatory requirements are fulfilled for countries
participating in a clinical study and authorizes the release of countries to receive investigational product

• Assists in reviewing and confirming completeness of essential site documents in order to release sites
participating in a clinical study to receive investigational product.

• Assists in ensuring completeness, accuracy, and delivery of Regulatory documents to the electronic
trial master file, and identifies and resolves discrepancies as needed

• Assist with periodic regulatory compliance checklist reviews across all programs

• Assists in providing general inspection readiness support by participating in inspection readiness
task forces, providing support in staging required regulatory department documentation, and providing
Regulatory ready room support during health authority inspections

• Assists in the preparation of CAS and USAN applications

• Assists in supporting development and maintenance of Regulatory standards and procedures in
accordance with all applicable Regulatory regulations, guidance, and specifications.

Requirements:

• eTMF and eCTD experience, Regulatory inspection readiness experience a plus

• Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications

• Can work independently (some guidance from direct manager anticipated), ability to multi-task, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills

• Working knowledge with MS Office applications and Adobe Acrobat. Previous exposure to
electronic document management systems (EDMS) is desirable

• 3 years' experience in pharmaceutical industry preferably in a regulated environment (Regulatory Affairs, Clinical trial support)

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.