Johnson & Johnson Careers
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Regulatory Legal Counsel
Requisition ID: 1805622445W
The Regulatory Legal Counsel – ASPAC (China) will provide regulatory legal support to the J&J businesses within China, dealing with a complex and broad variety of matters.
Her/his scope of work will include:
· •♦Being the key legal contact for various functional groups on regulatory matters across China, notably Regulatory Affairs, Quality, Medical Affairs, Medical Safety, Governmental Affairs & Policy, Health Care Compliance & Privacy.
· ♦Advising on regulatory compliance issues arising out of a drug or medical device product’s lifecycle, such as compliance with CLP, GCP, GMP and GSP; compliance with regulations on administration of human genetic resources; product labeling compliance; product promotion and advertising (including social media) compliance; and issues relating to market access programs (such as patient assistance programs).
· ♦Handling local FDA investigations/inspections in relation to product labeling or quality issues.
♦Co-ordinating legal aspects of field safety actions (such as product recalls or other field corrective actions).
· ♦Reviewing external communications on regulatory compliance issues to regulatory authorities and external customers.
· ♦Maintaining update-to-date knowledge and expertise on pharmaceutical, medical device and cosmetics legislation in China and providing updates on legislation developments to both legal and business colleagues.
· ♦Conducting trainings to internal clients on marketing, healthcare (anti-corruption) and regulatory compliance.
· ♦Screening and being closely involved in shaping the external environment together with regulatory affairs/government affairs, alerting management and assessing and training on impact.
· ♦Assisting in licensing, due diligence in acquisitions/divestures and other commercial agreements, focusing on the regulatory aspects and risks of such transactions.
· ♦Advising on privacy and data protection issues such as requirements on cross-border transfer of data collected in China.
The Regulatory Legal Counsel – ASPAC (China) will be a member of the J&J Law Department and part of the broader ASPAC legal team. The role will report into the International Regulatory Legal Team within the Global Regulatory Law Group.
The Regulatory Legal Counsel – ASPAC (China) will be a self-starter and shall successfully work in “virtual” teams and cross-functional working groups. She/he is expected to build effective relationships with the functional business clients and shall partner with the other J&J attorneys present in the region and globally.
A successful candidate will be based in Shanghai or Beijing, China, and should be prepared to spend 10% to travel, both within and outside the region (including the US).
·♦Bachelor or Master of Law degree and China National Bar certificate.
· ♦Supplementary degree or LLM abroad considered an asset.
· ♦Minimum 5 years of relevant experience in regulatory legal work in the life sciences industry, acquired in:
·an international law firm or consulting/lobbying services organization,
·and/or legal department of an international corporation in the healthcare industry.
♦Experience with US regulatory environment is considered an asset.
· ♦Strong legal and business judgment with an orientation to finding solutions.
· ♦ Excellent communication skills, with the ability to articulate complex issues both orally and in writing.
· ♦Strong interpersonal and leadership skills, with a track record of collaboration with colleagues.
· ♦Global mindset and a strong sense of integrity, with the ability to establish trust-based relationships with internal and external stakeholders.
· ♦Fluency in Mandarin and English.
Johnson & Johnson Medical Shanghai Ltd. (7055)