Catalent Pharma Solutions Regulatory Compliance Specialist in Kansas City, Missouri
Catalent Pharma Solutions in Kansas City, MO is hiring an Regulatory Compliance Specialist for the Manufacturing group. This person will be responsible for supporting the state of regulatory compliance at the Kansas City site through the following programs: Commercial Data Reports, Drug Product List, Client Submission support, Audit Ready 365, and Quality Technical Agreements or other related compliance issues and actions This person should be detail-oriented, analytical, and be able to work well independently.
This is a full-time role position: Monday – Friday, 8:00AM-5:00PM.
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and roller compaction.
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.
Own and manage the Commercial Data Report program, including schedule creation/revision and opening meetings to assure completion of Commercial Data Reports by the communicated due date in support of the Customer’s Annual Product Review.
Create, process, and track Client requested documentation in support of worldwide Regulatory submissions. Involves direct interaction with Clients, Project Management, and Catalent Senior Leadership.
Support regulatory inspections and other quality or regulatory activities. Pre and Post Inspection activities may include opening presentation preparation, back-room participant, retrieval and/or review of documentation, contact for SMEs, client notifications, investigations, updating of annual statements and other tasks as required.
Aide in the annual updating of the Site Master File and Drug Product Listing, upon request.
Provide support for the Quality Technical Agreement (QTA) program, as required, according to standard operating procedures and regulatory requirements including new QTAs and the required review of existing QTAs. Involves direct interaction with Customers, Project Management, QPs, Quality at other Catalent sites and Catalent Corporate Compliance for the generation and approval of QTA.
Support regulatory inspections and other quality or regulatory activities as requested including Opening and Pre-Approval Inspection presentation preparation, back room participant, retrieval and/or review of documentation, contact for SMEs, client notifications, updating of annual statements and other tasks as required.
Update Quality standard operating procedures and forms as required.
All other duties as assigned;
Bachelors degree in a related field is required
While no additional experience is required, 3 or more years in a related Scientific or Quality field is highly preferred
Proficient in basic computer usage, Word, Excel, and Sharepoint
Prior knowledge and experience in GMP environment is highly preferred
Strong written and verbal communication skills
Ability to work effectively under pressure with changing priorities and deadlines
Working knowledge of regulatory compliance related to pharmaceutical and biotech industries
Good organizational skills and a strong attention to detail
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
Why you should join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
19 days of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Employee Stock Purchase Program
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Community engagement and green initiatives
Generous 401K match and Paid Time Off accrual
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
GymPass program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) 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 firstname.lastname@example.org for us to investigate with local authorities.
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