Sr. Manager, Clinical Compliance

Jul 17, 2017
Jul 19, 2017
Employer Type
Direct Employer
Employment 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.

Within the team of Clinical Compliance this position will provide guidance and support to clinical study teams in indentification and investigation of potential serious GCP compliance issues at investigator sites, with internal process and with vendors conducting clinical trial activities. The incumbent will develop tools and reports to facilitate the completion of CAPAs, provide data to support trending/signal detection of potential compliance concerns and the development of other tools to assist the organziation in minmizing risk and ensure quality is integrated into our processes. In addition, this position may provide support in the preparation and conduct of Regulatory Inspections (e.g. FDA Sponsor Monitor Inspections). This position will also support the resolution of QA audits and resulting CAPA actions.

  • Assists with conducting Suspected Serious Non-Compliance (SSN) Investigations, completion of follow up activities and issuance of SSN documentation.
  • Tracks finalization of audit response documents and ensuring CAPA closure for audits and SSNs
  • Facilitates and assists CPMO and Clinical Study teams in developing Corrective and Preventative action (CAPA) plans as a result of QAA audits (Process, Site and Vendor Audits)
  • Bachelors with at least 6 years of relevant industry experience.
  • At least 3 years experience working in a clinical compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills in Good Clinical Practice and Regulatory Inspections.
  • Excellent communication skills and ability to work with people in all levels of the organization and externally.
  • Demonstrated skills in working independently and in a team environment
  • Demonstrated experience in development of CAPA plans to address potential non-compliance.
  • Experience developing trending reports and analyzing potential quality issues (e.g. root cause analysis, critical thinking skills, etc.)
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 Regenerons 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.