Kelly Services Global Regulatory Affairs Associate Director, CMC in Lexington, Massachusetts
Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Global Regulatory Affairs Associate Director, CMC at a prestigious Fortune 500® company working in Lexington, MA.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within.
Job Title: Global Regulatory Affairs Associate Director, CMC
Pay: $75 - $96 depending on experience
Position Summary :
Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing a Core Dossier for Module 3 and preparing Module 3 documents to support Marketing Authorization Applications in Japan and Brazil. Provide support to other HA interactions as required.
Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into submissions for marketing authorizations. Provide Reg CMC support for development programs to ensure that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned. Manage preparation of Core Dossier, Japan and Brazil applications in a timely manner to meet corporate objectives.
Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives.
Job Duty and Description
Develop global CMC Core Dossier for Module 3
Prepare Module 3 Marketing Authorization Application for Japan
Prepare Module 3 Marketing Authorization Application for Brazil.
Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines.
Provide CMC regulatory guidance to project / product teams.
Education and Experience Requirements
B.A. / B.A. / M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field. Minimum of 4 years’ experience in pharmaceutical product development including significant experience in CMC regulatory affairs with a strong biologics background or equivalent. Experience in directing interactions with regulatory authorities desired. Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance.
Significant coordination with cross-functional teams internally and regulatory authorities externally.
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Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
Kelly Services is an Equal Opportunity Employer
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.