Senior Regulatory Affairs Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Bangkok, Bangkok, Thailand

Job Description:

Essential Job Duties and Responsibilities

The Senior Regulatory Affairs Specialist is responsible for maintaining all pharmaceutical product licenses in Thailand, Cambodia and Myanmar market. Ensure business continuity through the product registration, lifecycle management, regulatory compliance and vital documents management.

• Prepare, coordinate and submit regulatory applications, including registrations, variations, renewals and lifecycle maintenance activities.
• Ensuring that life-cycle management activities of pharmaceutical products are carried out in compliance with Johnson & Johnson standards.
• Monitor regulatory changes and assess potential business impact to ensure compliance as per local market regulations or requirements, as well as internal standard procedures.
• Managing all changes and quality issues related to regulatory activities according to internal procedures.
• Coordinate communications with the Thai FDA and relevant stakeholders.
• Coordinating with cross functional team to ensure that new products and/or approved variations are implemented on time for uninterrupted supply chain including launch readiness.
• Ensuring timely implementation of package inserts and packaging components.
• Ensuring that product package inserts are not deviated from the international package inserts or otherwise follow management of local labeling deviation.