What are the responsibilities and job description for the Regulatory Compliance Specialist position at Catalent?
Regulatory Compliance Specialist
Position Summary
The Regulatory Compliance Specialist is primarily responsible for the day-to-day operations related to supplier quality assurance, support of audits, both external and internal, and change control activities. The role is also responsible for ensuring the site is compliant with Catalent procedures.
The Role
Support supplier quality assurance activities, including:
Work with other departments to onboard new suppliers and new materials, packaging components, manufacturing consumables, etc.
Complete and/or support new supplier qualifications and existing supplier re-qualifications.
Manage communication with suppliers for completion of qualification documents and required regulatory documentation.
Assist with maintaining the site’s Approved Supplier List.
Complete supplier and material risk assessments as required.
Support assessment of change controls related to suppliers and/or material changes.
Other duties as assigned.
The Candidate
Bachelor’s degree preferred.
2 years relevant experience in pharmaceutical or related industry required.
Fully competent in the use of common computer software – Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Power Point, and Microsoft Project.
Must be well organized and detail and multi-task oriented.
Must be able to interact effectively with a variety of individuals and personalities within and between departments and customers.
Why You Should Join Catalent
Several Employee Resource Groups focusing on D&I
Employee Stock Purchase Program
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.
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 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.
