Kelly Services Regulatory Affairs Specialist in Charles City, Iowa
Regulatory Affairs Specialist - Midwest area
The Regulatory Affairs Specialist will be responsible writing, review and submitting regulatory submissions.
Write, review, compile and submit new Drug Master Files/CEP Common Technical Documents and their submission with the relevant Regulatory authorities.
Review, compile and submit amendments, updates and updates to existing DMFs for filing with the relevant Regulatory authorities.
Manage document and maintain all CCC regulatory filings with Health Authorities.
Serve as primary site liaison with Health Authorities concerning regulatory filings (i.e. issue LOA¿s, responding to deficiency letters, requests for additional information).
Serve as a liaison with new and existing customers concerning regulatory filings (i.e. issuing CEPs, preparation and submission of Letters of Authorization, coordinate filings of EDMF/CDMF with MAA, communicate changes and proposed changes, coordinate responses to customer inquiries).
Obtain, maintain and manage site accreditation with foreign Health Authorities as Korean FDA, Indian FDA and PDMA (Japan).
Provide guidance and in-put to CCC project teams on regulatory requirements and guide compilation of DMFs/Registration Dossiers.
Review of various change controls for compliance to commitments made in Regulatory Submissions or requirements and complete assessments of regulatory impact.
Provide regulatory council on new and existing raw material, in-process and product specification and test methods.
Review of data received from R&D, manufacturing, analytical, supply chain and quality assurance departments.
Bachelor's degree in a life sciences discipline, chemistry preferred
7-10 years of relevant regulatory experience, preferably in an API manufacturing environment
Excellent communication skills
Good project management skills required
Experience in a manufacturing environment a plus
Familiarity with compliance requirements within cGMP, safety and regulatory environments
Ability to work in a highly independent and self-directed work environment.
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
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