Regulatory Affairs Sr Mgr

Category: Regulatory
Job ID: R-34971
Location: China – Hong Kong
Posted Date: March 14, 2017
Develop JAPAC regional regulatory plans to ensure successful registration and license maintenance of Amgen products. Contribute to the development of global filing strategies.

This role is:
An individual contributor role based in Hong Kong with interactions with the global regulatory team (GRT) in the US, and local regulatory representatives (LRRs) in the local offices.

This role reports to:
A regional regulatory group lead in the US

This role is accountable for:
• Developing and executing regional regulatory registration plan
• Representing the region in GRT, other cross-functional ATO-based teams and HK-based team
• Leading the product lifecycle planning
This role is responsible for:
• Advising the GRT and global product teams on regional considerations in developing product registration and license maintenance strategies
• Ensuring the regional needs are well defined and implemented in collaboration with relevant global, regional and local stakeholders
• Executing the approved regional regulatory registration plan
• Conducting regional life cycle management planning meetings

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 life cycle maintenance activities.
• 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

Key Activities
• 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, guidances, current regulatory environment and competitor labeling

Qualifications
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
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
Education & Experience (Basic)
Doctorate degree and 2 years of directly related experience
OR
Master’s degree and 6 years of directly related experience
OR
Bachelor’s degree and 8 years of directly related experience
Education & Experience (Preferred)
In-depth regulatory experience related to JAPAC region.
Broad knowledge of JAPAC countries legislation and regulations relating to medicinal products
Knowledge of drug development
Communication skills both oral and written
Ability to understand and communicate scientific/clinical information
Cultural awareness and sensitivity to achieve resul