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Manager, Regulatory Affairs, OTC, China

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Job Description


• Lead regulatory activities across a portfolio of OTC products
• Proactively build strategic regulatory insights into product registration strategies including due diligence opportunities to ensure fast introduction of new products (including new indications) by securing import licences and domestic licences
• Proactively partner with internal business stakeholders (local, regional, global), regional franchise teams and Cross-Sector RA partners to lead development of innovative regulatory strategies ensuring that regulatory requirements are incorporated upfront and project risks are understood and mitigations in place.
• Develop problem-solving strategies which drive efficiency within the project teams, ensure product compliance and deliver high-quality submissions per project timelines for both innovation and Life Cycle management projects (e.g. variations, renewals etc.)
• In an environment where regulatory issues are often uncertain, analyse complex problems, assess alternatives and propose solutions
• Build and sustain positive relationships with the local health authorities, and represent the company in regulatory industry associations to positively influence the regulatory environment
• Good knowledge of NMPA regulations and guidelines. 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
• Ensure effective people management and talent development, including coaching, training, development, performance review etc. and appropriately manage the budget and resources to support business objectives. Critical focus on capability building and creating a supportive, empowering culture for teams to lead from every seat.


Qualifications
• University Degree in Pharmacy, Biology, Chemistry or related Life Sciences
• Minimum 5 years’ experience in OTC registrations including approximately 2 years’ experience in a team leadership role - 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, which China NMPA views as a reference
• Good 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, strategic thinking and problem-solving skills supported by a good commercial awareness
• Strong interpersonal skills and ability to build effective working relationships at all levels in the organisation
• Proven ability to work independently and without supervision
• 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-
Other Locations
China-Beijing-Beijing
Organization
Shanghai Johnson & Johnson Pharmaceuticals, Ltd. (7048)
Job Function
Regulatory Affairs
Requisition ID
1905763976W