Sr Associate Regulatory Affairs - Uxbridge, United Kingdom - Amgen

Amgen
Amgen
Verified Company
Uxbridge, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Career Category

Regulatory


Job Description:


  • Job Description:
  • Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients. Amgen continues to be an entrepreneurial, sciencedriven enterprise dedicated to helping people fight serious illness.
  • Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen is searching for a Senior Associate for the Regulatory Optimization of Tactical and Strategic Support (ROOTS2) group within RA CMC. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries.
  • The RA CMC Senior Associate will interface with the Amgen global, international, site and biosimilars RA CMC teams and the device team for specific strategies or activities that impact a product. The RA CMC Senior Associate will be responsible for varying levels of product support, including leading projects, based upon their experience level.
  • Additional job responsibilities of the RA CMC Senior Associate include:
  • Contribute as a key member of the global regulatory CMC product team
  • Lead the organization and preparation of the CMC sections of global annual notifications to meet regulatory requirements
  • 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 crossfunctional special project teams

Basic Qualifications:
Master's degree

OR

Bachelor's degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or

Scientific experience

OR

Associate's degree and 6 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or

Scientific experience

OR

High school diploma / GED and 8 years of Pharmaceutical/Biotech and/or Healthcare and/or Med

Device and/or Scientific experience


Preferred Qualifications:

  • BS degree in Life Science
  • Experience in manufacturing, 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
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