Shun Jin Email & Phone Number

Singapore

Tuas, West Region, Sg

Basel, Basel-Stadt, Ch

Abbott Park, Illinois, Us

Responsible for all regulatory activates in Asia Pacific region. Provide regulatory direction for product development and support to develop most rapid successful strategy for approval to market products to meet business objectives; administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions; attract and develop superior regulatory professionals and regulatory competencies.

North Chicago, Illinois, Us

Proactively capturing and disseminating information that impacts the pharmaceutical regulatory environment in the JAPAC region. Influencing the regulatory environment through trade associations and communications with Regulatory Authorities. Providing strategic advice and guidance to the organization on regulatory requirements.

Tokyo, Jp

Provides leadership, direction and support for regulatory policy and cross-business regulatory initiatives within the company, actively influencing changing regulations and guidance affecting the company through participation in trade associations and interfaces with regulatory agencies.Direct activities associated with capturing international/cross-regional information, both internal and external, that impacts the quality, regulatory, and compliance areas of Takeda and keep management abreast of regulatory changes and the impact they could have on the organization.Direct and provide strategic regulatory guidance/counsel to local operational companies for activities designed to address emerging regulatory issues, incorporate strategic action, and advance the development of Takeda regulatory professionals.

Tokyo, Jp

I am based in Singapore now.• Provide in house expertise on APAC regional regulatory affairs to the global development teams• Support the Asia Clinical operations team in securing timely regulatory approval of clinical trials in all APAC target countries.• Maintain ongoing understanding of APAC and global regulatory environment and best regulatory practices• Responsible for devising/maintaining process to review and interpret regulatory authorities documents to provide to company feedback to regulatory authorities and provide guidance to global development functions• Preparing for and conducting meetings with regulatory agencies

Durham, North Carolina, Us

Provide overall supervision and guidance for regulatory affairs for pharmaceutical products in Asia Pacific region. Lead the regulatory affairs team in all Asia Pacific countries with 20+ team members.Fulfill the line responsibilities, in both administrative and technical aspects, for direct reports.As a senior management team member in Asia, provide strategic advice for growth of business in the region. Maintain and develop health authority network in Asia. Analyze and interpret the drug regulatory trend in Asia Pacific and influence the regulatory environment to support company business.Manage regulatory projects including all kinds of submissions for CTA/IND/MAA/NDA etc.Responsibilities also include participating in and contribute to project bids, including client presentations, maintaining an agreed level of productivity/billability and a positive, results-oriented work environment, providing consultation, and facilitate the direct reports to manage the assigned projects to keep project on time and within budget, allocating proper resource to deliver the project timely, implementing process improvements, in conjunction with the Management team, in response to client and team feedback and quality audits and other regulatory related tasks. The service scope also covers medical device and health food products.

Chicago, Us

To manage the Asia Pacific Regulatory Affairs group including responsibility for all pharmaceutical regulatory activities in support of the compliance, new production registration, variation submission and promotion of GEHC pharmaceutical products in manufacturing sites, subsidiaries and distribution markets within the region (about 20 countries). Regulatory team has 9 RA members based in the different countries in the region. To be RA global leadership team member. Directly reports to Global Head of RA.

Acquired by GE in 2004.

Acquired by GE in 2004.

New Brunswick, Nj, Us

Product registration submission document preparation, submission, follow up etc.

Tokyo, Jp

Responsible for product registration document preparation, submission and follow up.

Responsible for new drug development.

Master, Business Administration

Bachelor, Pharmacy