R&D Partners is seeking to hire a Senior Manager, Regulatory Affairs III in Foster City, CA.
Your main responsibilities as a Senior Manager, Regulatory Affairs III:
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, company 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.
What we are looking for in a Mgr, Medical Writing:
BA/BS, MS or Ph.D or equivalent education.
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 co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
Why Choose R&D Partners ?
As an employee, you have access to a comprehensive benefits package including:
Medical insurance PPO, HMO & HSA
Dental & Vision insurance
401k plan
Employee Assistance Program
Long-term disability
Weekly payroll
Expense reimbursement
Online timecard approval
Pay Scale:
$166,400 $208,000 ( Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
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