Senior Regulatory Affairs Associate- CMC Biologics
Parexel, Indiana, PA, United States
Senior Regulatory Affairs Associate
5 to 8 years of experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada, Switzerland, Australia. Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective. Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada, Switzerland, Australia. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries. Strong communication and collaboration skills, ability to work independently. EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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5 to 8 years of experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada, Switzerland, Australia. Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective. Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada, Switzerland, Australia. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries. Strong communication and collaboration skills, ability to work independently. EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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