Johnson & Johnson 职业机会
Director, Regulatory Affairs
Requisition ID: 1905730990W
Integral member of China OTC senior management team and APAC RA leadership team. Shape regulation environment and provide leadership, oversight and successful execution of regulatory strategies supporting business plans. Critical focus on talent development, capability building and creating a supportive, empowering culture for teams to lead from every seat.
Build strategic regulatory insights into local commercial strategies. Lead all regulatory activities encompassing obtaining and maintaining marketing authorizations. Ensure fast introduction of new products including new indications by securing import licences, domestic licences (some may include conducting of local Clinical trials) and supporting launches via Free Trade Zone. Maintain and support communications with Health Authorities, governing bodies, Industry Associations and third parties. Ensure regulatory compliance.
Proactively partner with internal business stakeholders (local, regional, global) to lead development of innovative regulatory strategies delivering fastest introduction of products in China. Ensure that regulatory requirements are incorporated upfront. Serve as regulatory counsel in determinations of regulatory licencing and entry strategies including anticipated risks for products and claims
Build and sustain positive relationships with the local health authorities, and represent the company in regulatory industry associations to positively influence the regulatory environment
Collaborate with the APAC RA leadership team in establishing short- and long-term strategic goals and direct implementation to achieve China OTC business objectives.
Ensure effective people management, including coaching, training, development, performance review etc. and appropriately manage the budget and resources to support business objectives
Establish procedures to achieve efficiency within the RA department by collaborating cross-functionally to ensure product compliance in a timely manner and deliver high-quality submissions per project timelines
Monitor the regulatory environment locally, and globally and provide timely assessments to business leaders of the impact of new/changing regulations on the current and future pipeline. Provide consultation, interpretation and advice to relevant departments to ensure on-time compliance with regulatory guidelines/directives/national requirements
University Degree in Pharmacy, Biology, Chemistry or related Life Sciences
Minimum 5 years in a leadership role, managing team members and partnering with senior business leaders
Extensive RA experience (10+years) at both operational and strategic levels – OTC experience preferred- ability to critically analyse and apply knowledge to develop innovative regulatory strategies
Multinational company experience desired - understanding western approaches and working well with international teams, whilst at the same time understanding domestic company practices to leverage
Good understanding of US and EU regulatory framework, including International Standards which China NMPA views as a reference
Wide External engagement network across NMPA, Provincial FDA’s and Industry Associations
Ability to operate across a wide range of business activities, including in-licencing projects
Ability to work in a matrix organization, managing multiple complex projects, priorities and systems simultaneously. Able to re-prioritize in an ever-changing environment whilst under pressure, and agility to manage emergency situations
Strong Leadership skills - Team and change management capabilities/experience; ability to integrate team into one cohesive group towards the same goal. Proven ability to lead, engage and inspire others
Confident and articulate communicator (both written and verbal), with the ability to convey and present highly complex information to others clearly and logically
Full command of English and relevant local language