Regulatory Compliance Specialist

Position Summary

Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full life-cycle supply. With time-tested experience in development sciences delivery technologies and multi-modality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality and compliance and to the safety of every patient consumer and Catalent employee. Catalents Winchester location is the flagship US manufacturing location for large scale oral dose forms with integrated analytical and development services. With 28 years of expertise in product development technology transfers and commercial manufacturing and roots in industry-leading Glatt technology.

The Regulatory Compliance Specialist is primarily responsible for the day-to-day operations related to controlled substance management support of audits both external and internal and change control activities. The Regulatory Compliance Specialist is also responsible for ensuring the site is compliant with Catalent procedures.

Monday-Friday 8 AM-5 PM. This position is 100% on-site at Winchester site.

Catalent is committed to a Patient First culture through excellence in quality and compliance and to the safety of every patient consumer and Catalent employee.

The Role

• Assist with maintaining site regulatory documents (i.e. Site Master File and State Licensure)

• Support client Regulatory Submissions

• Support internal and external audits and client relationship management

• Assist in training other departments related to new/updated procedures.

• Schedule and support customer audits of the facility and systems.

• Communicate with applicable departments to obtain responses to audits; compile and distribute audit responses into report format.

• Follow-up with appropriate department representatives to ensure corrective actions have been incorporated within the committed time frame.

• Other duties as assigned.

The Candidate

• Bachelor of Science required. 5 years of pharmaceutical or controlled substance handling experience may be substituted.

• 3 years relevant experience in pharmaceutical industry preferred.

• 21 CFR 200 toto End

• cGMP regulations/guidance pertaining to Pharmaceutical industry.

• Individual may be required to sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Individual will be required to stand for hours for audit lifting overhead reaching less than or equal to 15 lbs. with the ability to potentially be able to lift up to 35 lbs and push/pull 40 lbs.

Why You Should Join Catalent

• Several Employee Resource Groups focusing on D&I

• Tuition Reimbursement Let us help you finish your degree or earn a new one!

• Generous 401K match

• 152 hours accrued PTO 8 paid holidays