Johnson & Johnson Careers

RA Associate Director -OTC

Shanghai, China
Regulatory Affairs


Job Description

Requisition ID: 1905738452W

• 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


Qualifications
• 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


Primary Location
China-Shanghai-Shanghai-
Organization
Shanghai Johnson & Johnson Pharmaceuticals, Ltd. (7048)
Job Function
Regulatory Affairs
Requisition ID
1905738452W