Job ref no.: CT3116513-01#2278

Senior Manger CMC Regulatory Affairs

Amgen

Description

  • Responsible for generation of the region specific regulatory documents (CTAs and MAAs) and regulatory intelligence for multiple products.
  • Primary point of contact and interface with the Regional Regulatory Lead (RRL) and Local Regional Representative (LRR) for specific strategies or activities that impact a specific region.
  • Support the RA CMC Global teams with Clinical Trial initial applications and amendments, and future Marketing Application preparation.
  • Work within the Amgen document management system for the compilation of submission documents, tracking of submissions and approvals dates, and response to question preparation
  • Facilitate product development and global registration by developing and executing regulatory strategies for product manufacturing and quality programs throughout product lifecycle.
  • Contribute to the development of the Regional RA CMC strategy and execute the preparation of CMC components of CTA and NDA filings for all Amgen products in collaboration with the RRL and RA CMC JAPAC Regional lead
  • Responsible for organization and preparation CMC investigational product amendments and post-market supplements in collaboration with RA CMC Global Lead.
  • Ensure appropriate compliance with archiving/tracking and monitor metrics from tracking systems including IMR.
  • Oversee all regulatory obligations in relation to the region under responsibility, work with the team and cross functionally to ensure any necessary alignment to these obligations.
  • Conduct contingency regulatory planning/risk assessment for regional development and regulatory interaction strategies.

Basic

Qualifications

Doctorate degree & 2 years of Regulatory & Compliance experience

OR

Master’s degree & 6 years of Regulatory & Compliance experience

OR

Bachelor’s degree or & 8 years of Regulatory & Compliance experience

OR

Associate’s degree & 10 years of Regulatory & Compliance experience OR High school diploma / GED & 12 years of Regulatory & Compliance experience


Preferred

Qualifications

  • CMC-specific regulatory knowledge & experience
  • Strong & effective oral and written communication skills; proven ability to communicate effectively with different management levels.
  • Competent with Microsoft Outlook/ Word/ Excel/Power Point/Project
  • Ability to speak and read one or more of the following languages: Mandarin, Japanese, Korean,
  • Experience in manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
  • Regulatory CMC experience

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More job information
Job ref no. CT3116513-01#2278
Salary
  • N/A
Job Function
Industry
Employment Term
  • Permanent
  • Full-time
Experience
  • 2 years - 12 years
Career Level
  • Non-management level
Education
  • Degree