Instagram
youtube
Facebook

Associate Director Regulatory Affairs

18-20 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: PhD/BSc/MSc/BPharma/MPharma/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

This position at Amgen for Associate Director, Regulatory Affairs CMC represents a leadership role in regulatory affairs with a focus on CMC (Chemistry, Manufacturing, and Controls). It involves managing a team, fostering a culture of compliance, and contributing to the development and implementation of innovative tools to improve operational efficiency.


Roles & Responsibilities

Team Leadership and Development

  • Hire, train, mentor, and retain regulatory CMC staff aligned with departmental objectives.
  • Build a collaborative team environment, emphasizing Amgen's values and leadership principles.
  • Support staff growth through coaching, mentoring, and development programs.

Operational and Cross-Functional Collaboration

  • Ensure smooth integration of local and global teams.
  • Work with external stakeholders to enhance Amgen’s reputation and promote careers in regulatory CMC.
  • Collaborate with cross-functional teams to create and implement digital tools and automation for efficient operations.
  • Develop and refine regulatory processes for alignment across products.

Compliance and Delivery

  • Maintain compliance with local and global regulations and codes of conduct.
  • Ensure data integrity and accuracy within internal regulatory systems.
  • Monitor and improve business performance by addressing emerging challenges.
  • Oversee timely and accurate submission of deliverables.

Qualifications

Basic Qualifications

  • Doctorate degree with 3+ years of directly related experience; OR
  • Master’s degree with 10–14 years of directly related experience; OR
  • Bachelor’s degree with 14–16 years of directly related experience; OR
  • Diploma with 18–20 years of directly related experience.

Preferred Qualifications

  • Experience in manufacturing, QC/QA, or distribution.
  • Strong background in Regulatory CMC, including global filings across development stages, regions, and modalities.
  • Experience leading matrixed organizations.

Knowledge and Skills

  • Expertise in organizational leadership, staff development, and regulatory operations.
  • Proficiency in process improvement, operational excellence, and automation.
  • Regulatory knowledge specific to CMC processes and requirements.
  • Familiarity with AI and digital tools to enhance regulatory operations.

What Amgen Offers

Amgen provides a comprehensive benefits package and a collaborative culture that fosters personal and professional growth. From competitive compensation to Total Rewards Plans, Amgen supports its employees at every stage of their journey.


How to Apply

If you are ready to take on this impactful leadership role, apply now at careers.amgen.com.