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: Responsible for managing inspections through the prep, performance and follow up of items requested by international regulators, and supporting regulatory inspection and partner audits in the creation and management of inspection content ensuring it is organized, current and readily accessible during operations. This position will help cross-functional teams prepare for and follow up on inspection items as well as performing administrative duties in support of site inspection readiness. The role also requires an unwavering commitment to a culture of trust, teamwork and transparency.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Assist with compiling information and requests in support of regulatory inspections and partner audit operations (includes determining the content required to fill those requests).
* Maintain evidence files for inspections and audits (includes preparation of area subject matter experts to present the files).
* Maintain action lists and follow up on the completion of actions in support of site inspection readiness (includes review of actions to determine if they are sufficient to close items).
* Prepare action reports for IMT and site personnel including but not limited to; weekly status updates, metrics, operation reports.
* Develop good communication and working relationships with site functional areas to include department leaders and line managers.
* Maintain team documents and records ensuring content is accurate and up to date supporting inspection readiness.
* Manage documents both written and electronic and those stored on the IMT SharePoint.
* Support logistics during inspection operations in assigned inspection role.
* Support and coordinate internal meetings and or meetings with site departments;
o Schedule and organize meetings.
o Take meeting minutes.
o Follow up on assigned actions with other groups.
o Perform updates of inspection readiness documentation (i.e. opening presentation or inspection binders).
o Lead or support additional projects and activities as assigned by supervisor.
Knowledge and Skills:
* Must be quality minded, action oriented and organized.
Education and Experience:
* Must display strong interpersonal communication skills and the ability to interact with team members with tact and diplomacy.
* Have the ability to handle multiple priorities and tasks with time management skills and prioritizing tasks for completion.
* Computer skills needed; proficiency in MS Office (Word, Excel, PowerPoint) and experience with SharePoint.
* Must have the ability to successfully coordinate activities with site functional departments.
* Requires BS/BA in a physical science and 3 + years of GMP experience.
* Associates degree with 5+ years of equivalent/relevant experience may be substituted in lieu of advanced educational requirement.
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.