Director, Regulatory Affairs CMC, Intercontinental - Uxbridge, United Kingdom | Biospace
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Director, Regulatory Affairs CMC, Intercontinental

Amgen

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Location:
Uxbridge, United Kingdom
Posted Date:
8/17/2017
Position Type:
Full time
Job Code:
R-35997
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Job Title

Director, Regulatory Affairs, CMC Intercontinental

Job Location:

  • Uxbridge, UK

Salary:

  • Competitive Salary + Comprehensive Benefits Package

Posting Date:

  • 4th August 2017

Closing Date:

  • 10th August 2017

About Amgen:

Amgen is one of the world's leading independent biotechnology companies, with global revenues in excess of $18 billion and over 18,000 employees. For more than 30 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

Group purpose:

  • Strategic Regulatory Affairs CMC partner for key stakeholders in Global Regulatory Affairs and Safety  (GRAAS) (Therapy Areas and Affiliates) and in Operations (Global & International Operations, Global & International Quality, Alliance Management & manufacturing sites) for CMC & GMP issues related to defined regions (Central and Eastern Europe, Middle East and Africa, Latin America and Asia Pacific)
  • Strategic partner for Global RA CMC Product teams in ensuring product development and supply chain strategies are aligned with regulatory/GMP requirements and limitations in defined regions
  • Strategic RA CMC partner for GRAAS Affiliates & Operations / Quality for the integration of manufacturing sites in defined regions into the Amgen network

Duties and Responsibilities:

  • Establishment of appropriate RA CMC infrastructure (processes, templates, intelligence & policy databases) to enable successful regulatory approvals in defined regions (Central and Eastern Europe, Middle East and Africa, Latin America and Asia Pacific)
  • Establishment of appropriate cross-functional processes, policies & standards to enable successful launch and supply continuity in defined regions
  • Develop & leverage RA expertise in both CMC and Regional requirements to guide successful product development strategies & supply chain continuity
  • Advising Global Product Teams on regional RA CMC requirements influencing product strategy
  • Facilitating key regional decisions which impact global product development and filing strategies
  • Providing recommendations regarding regional strategy to GRAAS (e.g. GRRC, GCRB) and Operations Senior Management (e.g. OGC) for endorsement
  • Representing RA CMC at GRAAS (e.g. GEMST) and cross-functional governance forums
  • Managing regional regulatory requirements and complex relationships (particular focus on Latin America)

Requirements

Skills, Qualifications and Experience requirements:  

  • Degree (BSc, MSc, PhD) in Life Sciences
  • In depth experience of pharmaceutical/biotechnology or medical device industry
  • Broad experience of Regulatory Affairs
  • English language skills
  • Spanish and/or Portuguese  language skills are a strong requirement due to high workload and complex relationship management in Latin America
  • Specific expert experience in one or more of the defined Regions including Latin America, Canada, Middle East and Africa
  • Broad experience in Emerging Markets regulatory affairs, supporting complex submissions for both biotechnology and chemically derived products.
  • Extensive Global Regulatory CMC experience
  • Biotech Manufacturing Experience
  • Biotech Market Application experience that includes leading complex biological product submissions
  • Quality Control experience that includes leading new testing site registrations
  • Biological Drug Substance experience that includes leading new site registrations
  • Product Formulation and Sterile Filling experience that includes new site registrations
  • Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
  • Excellent interpersonal skills

Amgen is an equal opportunity employer.

HJE2017