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Regulatory Affairs Mgr
Amgen
posted 11hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Additional job responsibilities include:
Lead submission for annual reports, facility registrations, facility renewals, and product renewals
Potential to oversee or manage staff
Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams
Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions
Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications
Coordination, preparation, collection and/or legalization of CMC country specific documents
Document and archive CMC submissions and related communications in the document management system
Initiate and maintain CMC product timelines at the direction of product lead
Interface with the regulatory operations team
Train staff on select CMC procedures and systems
Provide report status of activities and projects to teams and department
Participate in cross-functional special project teams
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR
Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Preferred Qualifications:
Experience managing or overing staff members
Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
Regulatory CMC specific knowledge and experience
Mature project management and organizational skills
Strong and effective oral and written communication skills
Experience in Veeva Vault platforms
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
International travel
Day Shift
Amgen Benefits
Submitted by Company
Health Insurance Child care Education Assistance Employee volunteer program and company matching donation program Flexible work environment Competitive base pay and annual bonus opportunities
Submitted by Employees
View more benefits 
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