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Associate Director Regulatory Affairs

18-20 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

How Might You Defy Imagination?

At Amgen, we believe that true innovation happens when talented people come together to make a lasting impact. Our mission is to serve patients, and as one of the world’s leading biotechnology companies, we’re at the forefront of pioneering new treatments. If you're ready to join a team that’s as passionate about shaping the future as you are, this is your opportunity.


Regulatory Affairs Associate Director – CMC

In this critical role, you will drive the success of our Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) department. Your leadership will ensure the development of a high-performing team, the creation of systems that streamline operations, and the continuous improvement of regulatory processes. You’ll be responsible for hiring, training, and retaining talented staff while ensuring compliance and efficiency within the team.

What You Will Do

As the Regulatory Affairs Associate Director, you will:

  • Lead Staff Development: Hire, train, develop, and retain staff to meet the operational objectives of the RA CMC department.
  • Promote Cross-Functional Collaboration: Ensure seamless interaction between local and global teams, fostering effective communication and collaboration.
  • Drive Process Improvement: Partner with colleagues across functions to enhance efficiency, implementing digital tools and automation to streamline operations.
  • Support Regulatory Compliance: Ensure all regulatory affairs processes are compliant with local and global regulations and codes of conduct.
  • Monitor and Recommend Changes: Track business performance, recommending adjustments to meet emerging challenges and opportunities.
  • Foster a Positive Team Culture: Embody and promote Amgen’s values and leadership attributes, while ensuring a culture of compliance.
  • External Relations: Collaborate with local academic and industry partners to raise Amgen’s profile in the RA CMC field.

What We Expect of You

We are looking for a visionary leader with:

Basic Qualifications

  • Doctorate degree and 3 years of related experience, or
  • Master’s degree and 10 to 14 years of related experience, or
  • Bachelor’s degree and 14 to 16 years of related experience, or
  • Diploma and 18 to 20 years of related experience.

Preferred Qualifications

  • Experience in manufacturing, testing (QC/QA or clinical), or distribution.
  • Expertise in Regulatory CMC and global regulatory filings across various stages of development and regions.
  • Demonstrated ability to lead matrixed organizations.
  • Operational excellence and process improvement experience.
  • Familiarity with AI tools and automation to improve workflow efficiency.

What You Can Expect of Us

At Amgen, we take care of our team as much as we take care of our patients. We offer:

  • Comprehensive Benefits: Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
  • Generous Retirement Plan: Company contributions to help you save for the future.
  • Work-Life Balance: Flexible work models and generous time-off policies.
  • Career Development: Access to learning opportunities and career growth.
  • Incentives: Competitive salary, bonus opportunities, and stock-based long-term incentives.

Join Us.

Be part of a team that defies imagination, creating innovative solutions to transform the lives of patients. Apply now and embark on a journey to change the world.

careers.amgen.com

Amgen is an Equal Opportunity Employer. We provide accommodations for individuals with disabilities during the application and interview process.