Senior Representative, Regulatory AffairsCatalent 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.The Regulatory Affairs department is accountable for the direct management and guidance regarding the organization’s cGMP compliance and regulatory affairs for biologics, sterile injectables, cell and gene therapy, inhalation manufacturing and analytical services. Regulatory Affairs will work with clients and internal cross-functional teams to provide regulatory strategy and support services for drug and combination products throughout the product lifecycle.The main responsibility of a Senior Regulatory Affairs specialist is to serve as a regulatory liaison to clients and internal functional departments.This position works days; Monday – FridayCatalent 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
Prepare accurate and quality documentation for client regulatory submissions; provide regulatory guidance and support for development and production activities
Maintain awareness of changes in global regulatory requirements for effective regulatory submissions and production documentation
Review regulatory and production documents to ensure compliance with global requirements, agreements, and other regulations
Serve as regulatory liaison with the applicable Health Authorities for assigned projects
Assist in the maintenance of facility registrations
Develop and implement regulatory strategies to facilitate registrations and strategies to facilitate client relationships; serve as a regulatory resource for clients
Other duties as assigned
The Candidate
Bachelor’s Degree, required; Master’s Degree, preferred
RAPS Certificate, preferred
5 – 8 years of relevant experience
6 years’ GMP experience, preferred
Must be able to read and understand English-written job instructions and safety requirements
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes
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 (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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
