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Company Introduction: Amgen is a leading global biotechnology company, renowned for its innovation and scientific excellence in human therapeutics. For over 40 years, Amgen has been committed to advancing the practice of medicine through groundbreaking discoveries. As a Fortune 500 company, Amgen serves millions of patients worldwide, offering solutions that fight serious illnesses. The company’s focus on scientific research, coupled with its entrepreneurial spirit, drives its dedication to improving the health of people everywhere.

Responsibilities in Job: As a Senior Associate in Regulatory Affairs, you will play a key role in Amgen’s Chemistry, Manufacturing, and Controls (CMC) division. The position involves a range of responsibilities including the following:

  • Lead Submissions: Oversee the preparation and submission of annual reports, facility registrations, renewals, and product renewals.
  • Collaboration with Teams: Interface with global teams to implement strategies that impact product manufacturing, quality programs, and regulatory submissions.
  • Document Preparation: Work on the preparation of CMC submission content, including IND/CTAs, amendments, new marketing applications, post-market supplements, and product renewals.
  • Project Management: Initiate, maintain, and track product timelines in collaboration with product leads.
  • Training and Mentoring: Provide guidance and training on CMC procedures and systems to junior staff.
  • Cross-Functional Involvement: Participate in special project teams to support regulatory affairs activities and ensure smooth submission processes.

Qualifications:

  • Basic Qualifications:
    • Master’s degree, or
    • Bachelor’s degree with 1-2 years of experience in manufacturing, QA/QC, or regulatory CMC in the pharmaceutical/biotechnology industry, or
    • Associate’s degree with 6 years of experience in manufacturing, QA/QC, or regulatory CMC, or
    • High school diploma/GED with 8 years of experience in the same fields.
  • Preferred Qualifications:
    • A BS degree in Life Science.
    • Experience in manufacturing, process development, quality assurance, quality control, or analytical development.
    • Regulatory CMC specific knowledge and experience.
    • Strong project management and organizational skills.
    • Effective communication skills (both oral and written).
    • Familiarity with Veeva Vault platforms.

Skills: The Sr. Associate Regulatory Affairs role requires the following skills:

  • Project Management: Ability to manage multiple tasks and deadlines efficiently.
  • Communication: Strong written and verbal communication skills to interact with internal teams and regulatory authorities.
  • Attention to Detail: Ensure accuracy in the preparation of regulatory documents and submissions.
  • Problem-Solving: Ability to address challenges and collaborate with various stakeholders for successful regulatory outcomes.
  • Regulatory Knowledge: In-depth understanding of CMC-related regulations and submission processes.

Application Link

Amgen Hiring In Regulatory Affairs
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