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Job Details

Regulatory Affairs Specialist

Location
Bloomington, IN

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Regulatory Affairs Specialist
Requisition ID
2018-4885
# of Openings
1
Job Locations
US-IN-Bloomington
Posted Date
2 days ago
(7/11/2018 7:12 PM)
Category (Portal Searching)
Regulatory Affairs
Overview
A Regulatory Affairs Specialist's primary role is to serve as a regulatory liaison and expert to clients and internal functional departments.
The Regulatory Affairs Specialist plays an important role in Catalent's Patient First philosophy by ensuring submissions are authored clearly and concisely without delays. This helps to facilitate the approval of drugs faster and therefore providing timely delivery of drugs to patients.
Responsibilities
Reviewing and updating facility drug master file(s)
Preparing accurate and quality documentation for client regulatory submissions
Providing regulatory guidance and support for development and production activities
Maintaining awareness of changes in global regulatory requirements for effective regulatory submissions and production documentation
Reviewing regulatory and production documents to ensure compliance with global requirements, agreements and other regulations
Serving as regulatory liaison with the applicable Health Authorities for assigned projects
Providing written documentation of interactions with regulatory agencies
Assist in the maintenance of facility registrations
Developing and implementing regulatory strategies to facilitate client relationships, as well as serve as a regulatory resource for clients
Assisting in assurance of regulatory compliance within site GMP systems
Qualifications
Bachelor’s degree
Master’s degree or higher preferred
2-5 years of experience in authoring submissions, including change management submissions, to the FDA (Specifically - NDA, BLA, IND, IMPD, MAA, CTA, PAS, CBE, Variations) –
510K experience is a plus
CMO experience is a plus
Combination products experience preferred
2 GMP experience required
Core Competencies
Manages Complexity
Ensures Accountability
Communicates Effectively
Situational Adaptability
Catalent in Bloomington takes great pride in offering employees a benefits package that includes:
Diverse, inclusive culture
Competitive salary with quarterly bonus potential
401(k) retirement savings plan with company match
Educational assistance/reimbursement
Paid time off
Medical, dental, and vision insurance
Life insurance
Flexible spending account
On-site fitness center and wellness programs
Excellent on-site cafeteria
Employee discount programs
Robust Employee Referral Program
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. More products. Better treatments. Reliably supplied.

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Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to ****
. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.
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