Regulatory Compliance Specialist

Catalent

8h•Onsite

About The Position

Regulatory Compliance Specialist Position Summary Typical working hours are Monday-Friday 8 AM-5 PM. This position is 100% on-site in Winchester, Kentucky. Catalent’s 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 supporting all external audits, including scheduling and hosting all customer and corporate audits, in addition to participating in regulatory audits. The Regulatory Compliance Specialist also supports internal audits and regulatory submission activities and ensures the site is compliant with Catalent procedures and government regulations. The Role Support audits/inspections of facility and systems (i.e. regulatory inspections, client audits, internal audits and corporate audits) Ensure compliance with cGMPs and applicable Catalent SOPs throughout the facility 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 Support tracking and trending of audit findings to facilitate site improvement efforts. Support regulatory submission activities Learn and communicate industry compliance trends and regulatory expectations within the site. Support corporate policy alignment within regulatory compliance Other duties as required in support of Catalent Pharma Solutions high performance The Candidate BS in Science or related degree; OR 5 years of pharmaceutical industry experience may be substituted for no degree. 2+ years of related work experience Knowledge of 21 CFR 200 to 299, 1300 to End cGMP regulations/guidance pertaining to Pharmaceutical industry Internal/external auditing experience preferred Individual may be required to sit for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor. 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 Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Requirements

BS in Science or related degree; OR 5 years of pharmaceutical industry experience may be substituted for no degree.
2+ years of related work experience
Knowledge of 21 CFR 200 to 299, 1300 to End
cGMP regulations/guidance pertaining to Pharmaceutical industry
Individual may be required to sit for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor.

Nice To Haves

Internal/external auditing experience preferred

Responsibilities

Support audits/inspections of facility and systems (i.e. regulatory inspections, client audits, internal audits and corporate audits)
Ensure compliance with cGMPs and applicable Catalent SOPs throughout the facility
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
Support tracking and trending of audit findings to facilitate site improvement efforts. Support regulatory submission activities
Learn and communicate industry compliance trends and regulatory expectations within the site.
Support corporate policy alignment within regulatory compliance
Other duties as required in support of Catalent Pharma Solutions high performance