Job Information
Catalent Pharma Solutions Senior Representative, Regulatory Affairs in Bloomington, Indiana
We're hiring for a Senior Regulatory Affairs Specialist to support compliance and regulatory affairs in Bloomington, Indiana!
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.
The Senior Regulatory Affairs Specialist serves as the liaison to clients and internal functional departments for all matters regulatory and compliance related. The regulatory affairs department is accountable for the direct management and guidance regarding these matters for our biologics, cGMP facility. The team works with clients and internal cross-functional departments to provide guidance and support services through a product’s life cycle. This is a full-time, salaried position and is 100% site based. The schedule is Monday – Friday 1st shift.
Catalent Biologics in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.
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.
The Role
Review new and update facility drug master files.
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.
Provide written documentation of interactions with regulatory agencies.
Assist in the maintenance of facility registrations.
Develop and implement regulatory strategies to facilitate registrations and client relationships.
Serve as a regulatory resource for clients.
Other duties as assigned.
The Candidate
Bachelor’s Degree required.
Master’s Degree preferred.
RAPS (Regulatory Affairs Certificate) preferred.
5-8 of regulatory affairs experience within pharmaceutical manufacturing, or regulated cGMP environment.
Must be able to read and understand English-written job instructions and safety requirements.
Why you should join Catalent:
Defined career path and annual performance review and feedback process.
Medical, dental and vision benefits effective on first day of employment.
Potential for career growth on an expanding team and organization.
152 hours of paid time off annually plus 8 paid holidays.
Community engagement and green initiatives.
Competitive salary with bonus potential.
Tuition reimbursement program.
Diverse, inclusive culture.
Generous 401K match.
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 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) .