Life Scientist as Senior Regulatory China Advisor
Posted on Mar 15, 2019 by F. Hoffmann-La Roche AG
The Senior Regulatory China Advisor is an expert on the evolving China CMC regulatory requirements. The role is impact-critical to the company; having strategic involvement across product portfolio for the second largest Roche Market.
In this job you will be responsible for the development of China's innovative regulatory strategies across the Roche Pharma Portfolio and throughout the product lifecycle. You will be working closely with the China Regulatory Group on prioritizing key CMC issues for policy outreach and shaping the external regulatory environment. In addition you will ensure up-to-date China requirements are maintained, communicated and integrated into project team's work plans, and aligned with project teams, Pharma Development Regulatory (PDR) China and the Regulatory Policy Group. You will: Lead and be accountable for the development, communication and execution of the China CMC Regulatory Strategy for products across the portfolio to:
Ensure that China requirements are incorporated in product planning strategies using a risk-based approaches' that minimizes China specific studies
Drive acceleration in filing and approval of timelines to maximize early access of Roche medicines in China using innovative regulatory approaches
Work across platforms in Pharma Technical Operations Regulatory (PTR) to ensure that the China strategy is inclusive and informed by the overall global CMC development strategies and priorities
Facilitate product lifecycle management to ensure continuous supply to China
Partner effectively and advise internal teams on optimized China regulatory strategies for development and commercial products, ensuring sound regulatory and science-based approaches
Partner effectively with China Pharma Development Regulatory Group based in Beijing and Shanghai to facilitate local execution of regulatory submissions and strategies
Establish an internal business process for including updated China regulatory requirements in PTR country requirements database, and proactively communicate such requirements to key stakeholders within Pharma Technical Operations
Actively engage in China CMC regulatory policy activities by prioritizing CMC topics of key importance to drive convergence of China regulatory requirements with international standards, and by coordinating educational outreach to China authorities, engaging appropriate global technical experts
Build and maintain relationships based on trust and respect with key China health authorities including NMPA, CDE, NIFDC and Chinese Pharmacopoeias
Gather, assess and timely communicate regulatory intelligence on China trends and relevant changes in the evolving regulatory environment to key stakeholders
Who you are You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
You preferably have a Master's Degree in life science disciplines; a Post Graduate Degree is a plus. Bachelor's Degree plus appropriate working experience in pharmaceutical industry is also appropriate.
You bring a minimum of 10 years of experience in Regulatory Operations and/or Policy, with a significant focus on China related activities. An in-depth understanding of China's CMC regulatory requirements across product lifecycle is a must, and you are broadly recognized as an expert in the field with established credibility across the industry.
In addition you bring the following skills and competencies:
Proven ability to develop innovative regulatory strategies and to adapt evolving regulatory requirements to maximize business value; you challenge the status quo to drive innovation
Proven ability to build and maintain strong relationships with relevant Health Authorities in China; you have excellent collaboration skills in a multi-cultural environment and the ability to work collaboratively with international teams and with external industry/scientific associations
Demonstrated capabilities to work effectively in a global matrix environment, while keeping management informed and consulted as needed
Strong verbal and written communication as well as presentation skills: you exhibit a professional maturity, confidence and competence
Ability to think and act decisively and effectively, and to quickly summarize complex issues and conclusions so as to expedite agreements and decision-making
Fluency in Mandarin Chinese and in English, both written and spoken is mandatory