Associate Regulatory Affairs Manager (OTC)
Johnson & Johnson (Thailand) Limited
jobsDB ref: JTH300003001247890
- Organizes and prepares registration documentation and related filings to regulatory agencies under planned approval timeline
- Coordinate with internal cross-functionally team, third party manufacturers and designated distributors to ensure the compliance checks for any changes and variation which may be occurred for OTC drugs under J&J Thailand and to ensure on-time delivery of registration documents to the request of health agencies or export country customers.
- Review labeling and advertising claims for compliance to local regulations.
- Proceed the approval of drug advertisement approval
- Determine and update regulatory requirements and relevant government regulations. Stay current on regulatory developments and trends in the industry that could affect J&J Consumer product line.
- Representing and networking with external parties such as associations and update the regulatory trends and new regulations that may impact the business
- Learning, understanding and implementing company SOPs and Best Practices for ensuring compliance according to regulatory and quality policy of the company.
- Update registration information and registration status in company database
- Execute the submission of FDA reports according to FDA requirements.
- Verify and approve for raw materials and finished product release approval.
Essential knowledge and skills:
- Bachelor’s Degree in Pharmacy
- Minimum 1-2 years’ experience in drug registration approval with Thai FDA
- Knowledge of FDA regulations and standards
- Core competencies required for this role:
- Good interpersonal and effective communication skills
- Analytical, attention to detail and problem-solving skills
- Good command in spoken and written English
HOW TO APPLY
If you possess what we are looking for, please logon to our careers website: www.careers.jnj.com. All applications must come through the portal (JJ Career website).
106 Moo 4 Latkrabang Industrial Estate,
Chalongkrung Road, Lamplatew,
Latkrabang, Bangkok 10520
jobsDB will send your application for review directly to Johnson & Johnson (Thailand) Limited
About Johnson & Johnson (Thailand) Limited
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Johnson & Johnson has more than 250 companies located in 57 countries around the world. Our Family of Companies is organized into several business segments comprised of franchises and therapeutic categories; Consumer , Medical Devices & Diagnostics , and Pharmaceuticals.
If you are looking for more than a job, and are inspired by the opportunity to create the future to bring quality of life to the world, we invite you to build your career with us.