Regulatory Compliance Specialist

Catalent Pharma Solutions • Winchester, KY

1d • 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

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
• 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.

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level