Job Description
Accountability
Ensure that all products to be released for sale in China comply with all appropriate statutory regulatory requirements, guidelines and all applicable internal Johnson and Johnson policy/procedures. To be able to proactively and effectively partner with external stakeholders including Government Agencies on healthcare policies development to ensure that the policies will serve the best interest for the consumers while will not create unnecessary barriers to business.
Collaborate with the China Business & Cross Functional Leadership Team, Regional Regulatory Affairs Leadership Team and other key local, regional and global stakeholders in establishing short and long term strategic goals and direct the implementation to achieve business objectives. Providing strategic direction to enable a business plan in line with global and local company objectives.
Key Responsibilities
Provide leadership and manage the overall performance of China OTC Regulatory Affairs team. Support a culture of continuous improvement when establishing procedures to achieve efficiency within the RA department, including interfacing with other departments to coordinate development of regulatory procedures and controls to ensure product compliance in a timely the manner. Manage expenses appropriately and plan allocation of funds and resources in line with Regulatory and Business strategies.
By means of performance review system, ensure self and staff are adequately trained, informed and developed. Ensure that an active coaching and development culture operates in the regulatory group with cross skilling and information / knowledge sharing.
Co-ordinate and oversee the due diligence, preparation, timely submission and approval of all regulatory submissions to China authorities to support the business plan.
Build strong relationships and partnerships with colleagues in Marketing/ Technical functions to ensure alignment of strategies and timeframes. Provide regulatory advice, ensuring compliance of J&J products in China. Provide strategic regulatory support and training to local business teams. Assist and advise marketing in developing strong and compliant promotional claims for key products and promotional campaigns.
Develop and maintain relationships with key personnel of government agencies and trade associations. Represent the company on industry matters of regulatory importance. Ensure the Regulatory Affairs colleagues also develop and maintain good relationships with Government Agencies and actively partner with these bodies to ensure the scientific based regulation/ policies.
Monitor the regulatory and competitor environment and provide assessments of the impact of new and changing regulations/guidelines on the company’s current products and pipeline. Represent the company and participate on appropriate industry committees as required;
Lead the team to proactively participate in regional/ global related projects and ensure that regulatory inputs of Pacific are incorporated into any new product development;
Being a member of Asia Pacific Regulatory Affair Leadership Team, he/ she is expected to make contribution to activities that have impact for the whole regulatory organization regionally and globally. This includes leading certain regional or global projects/ activities;
As appropriate and authorized, recruit and retain suitably qualified regulatory personnel and assign responsibilities accordingly;
Qualifications/Experience
Degree in Pharmacy, life science or similar discipline
8+ years related experience
Seasoned regulatory professional with established Health Authority and Industry Association connections;
Strong R&D background/ experience on Consumer Goods or OTC will be considered;
Functional Knowledge/Skills
Sound knowledge on healthcare sector
Comprehensive understanding of the regulatory process
Ability to analyse, interpret and communicate technical information
Good business knowledge and understanding
High level of computer literacy
Behavioral Competencies
Exceptional leadership, influencing and customer service skills.
Good verbal and written communication skills, including formal presentation skills
Ability to establish and maintain open relationships within the organization and authorities
The ability to build trust. The willingness to put the Credo top of mind for all decisions.
The ability to proactively sense and take action on problems and opportunities. The willingness to act quickly.
The ability to deliver business results and solutions and keep the focus on driving customer value. The willingness to assume personal ownership and accountability.
The ability to make tough calls and take risks. The willingness to learn from experience.
The ability to envision a better future. The willingness to serve as change agent.
The ability to zoom in or out as needed. The willingness to operate in two worlds simultaneously, e.g. growth and cost control, enterprise and operating company success.
The ability to see possibilities and cultivate new ideas. The willingness to experiment and learn.
The ability to motivate and empower others to achieve a desired action. The willingness to share talent.
The ability to work well across functions and groups and to build effective teams. The willingness to put interests of enterprise above own.
The ability to adapt and change as needed. The willingness to learn from others
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