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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: The individual will provide support during regulatory inspections and internal audits. This individual will also work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. Additionally, the individual will work with department leaders to build an inspection readiness capability across the organization.
Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
* Inspection Readiness;
o Benchmark leading practices and recommend improvements to make IOPS inspection-ready at all times.
o Maintain and organize inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials in the event of inspection or audit.
o Build and implement tools to improve IOPS inspection readiness.
o Identify trends in recent regulatory inspections and translate this to recommendations to enhance readiness.
o Work closely with other regulatory compliance team to close gaps and improve inspection readiness capabilities.
* Inspection Execution;
o Liaison with regulatory bodies, partners and key suppliers on audit, regulatory, and quality related matters and to provide guidance and advice to partners, suppliers and internal associates on regulatory and quality matters.
o Respond to incoming inquires during inspections and audits and ensure timely and accurate responses.
* Ensure marketed products are in compliance with global regulatory and guidance requirements primarily US and secondarily EU.
* Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for clinical and commercial operations.
* Interfaces with customer/partner quality organizations.
* Participates on internal committees/teams, as required.
* Provides advice and direction to other company departments on quality and regulatory issues.
* Requires BA/BS degree in in chemical engineering/chemistry/life sciences; process engineering or validation background & experience desired along with 10 years of relevant experience in a biotech or pharmaceutical environment.
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, disability status, protected veteran status, or any other characteristic protected by law.