Job Title : Senior Manager, CMC Regulatory Affairs, Biologics
Duration : 6 months (we would like to start with 6 months, with the potential to extend if the person is highly competent and a good resource for our team)
Location : Remote but preference is to have a candidate available to be onsite at the Foster City, CA location 2-3 days if possible
Pay Range : $80 - $100 / Hour
RESPONSIBILITIES
Responsible for preparation of the Quality sections of INDs / IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products.
Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. Ensure dossiers meet ICH and local regulatory requirements.
Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the International markets.
Liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
Co-ordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets and execute filings according to agreed priorities.
Maintain a current awareness of CMC registration requirements in each of the International regions and communicate key regulatory intelligence to the organization on a timely basis.
QUALIFICATIONS
BA / BS, MS or Ph.D
Significant experience in Regulatory Affairs CMC and / or relevant pharmaceutical industry experience.
Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and / or biologics products.
Biologics experience or drug-device combination product experience would be an advantage.
A proven ability to coordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
Proven strategic thinking skills, with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously.
In-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
Experience representing CMC regulatory affairs on regulatory and cross functional teams.
Top Required Skill Sets :
Significant experience in CMC Regulatory Affairs
Experience in leading and preparation of regulatory submissions
Top Nice to Have Skill Sets :
Experience with Veeva Vault, including RIM
Global regulatory expertise
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