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Senior Representative, Regulatory Affairs - Bloomington Indiana
Company: Disability Solutions Location: Bloomington, Indiana
Posted On: 04/25/2024
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 Certificate preferred.
- 5-8 of related experience within pharmaceutical manufacturing.
- 6 years of GMP experience preferred.
- Must be able to read and understand English-written job instructions and safety requirements.Why you should join Catalent:
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