Regional Regulatory Lead
China – Hong Kong; US – California – Thousand Oaks
Strategy and Execution
• Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen’s portfolio in compliance with registration plan and local regulatory requirements, with a focus on biosimilars.
• Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
• Leads development of regional regulatory documents and meetings in accordance with GRT strategy
• Advises the development of the regional product label by collaborating with LRR in the context of available and expected scientific data and regulatory guidance.
• Supports regional label negotiation activities
• With minimal supervision, participates in the development and execution of regional regulatory product strategies (RRP), including precedence, risk management and contingency planning
• Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global/local clinical development plans and objectives
• Develop regional regulatory plan (RRP)
• Compile regulatory submission dossiers for marketing applications and clinical trial applications.
• Lead team effort for Response to Questions (RTQs)
• Communicate regulatory strategies as appropriate such that expectations are understood.
• Communicate regulatory risks, develop and implement mitigation plans.
• Lead planning and preparation for agency interactions to ensure effective regional agency interactions consistent with the Global Regulatory strategy—includes contingency regulatory planning/risk assessment
• Ensure regulatory product records are properly archived (e.g. IMR, PMCs, pediatric and other agency commitments)
• Attend GRT, represent region to ensure regional requirements are properly taken into consideration in global development strategies.
• Partner with regional management and peers to ensure consistency in procedures and agency interactions
• Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Evaluates and communicate impact of relevant regional regulations, guidance, current regulatory environment and competitor labeling
Doctorate, Masters or Bachelors degree coupled with directly related work and leadership experience gained through directly managing people and/or teams, projects programs or directing the allocation of resources
At least 10 years of experience in Biosimilars and/or Biologics in a Regulatory Affairs capacity
Knowledge, Competencies & Skills
Knowledge and Skills
• Regulatory principles
• Working with policies, procedures and SOP’s
• Knowledge of national legislation and regulations relating to medicinal products
• Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals.
• Knowledge of drug development, particularly for biosimilars
Scientific / Technical Excellence
• Team work
• Communication skills – both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to anticipate and prevent potential issues
• Knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Understanding of regulatory activities and their touch points
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
• Cultural awareness and sensitivity to achieve results across both regional country and International borders.