Regulatory Affairs Specialist

Regulatory Affairs Specialist (Medical Devices)

Overall purpose of job:

The Regulatory Affairs Specialist, MD (Medical Devices), Thailand and CLM (Cambodia, Laos and Myanmar) is a member of local Regulatory Affairs department, responsible for:
• Providing input into the global regulatory strategy, identifying country requirement, and executing regulatory strategy for successful regulatory filings for new products / license renewal and maintenance licenses throughout product life cycle for responsible franchise(s)
• Collaborating with J&J Regulatory Affairs partners in Consumer and Pharma as part of the Country Regulatory Affairs Council

Essential duties and responsibilities:
1. The Regulatory Affairs Specialist MD will be a member of the local regulatory affairs department within Johnson & Johnson Medical, with responsibility to support regulatory aspects of the assigned product portfolio/s
2. Liaise and establish cooperative relationships with global regulatory colleagues to ensure understanding of regulatory requirements in Thailand and CLM and obtain documentation required for registration submissions;
3. Prepare submissions to the local health authority for new products, license renewal and variations to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary
4. Provide required documentation for registration submissions to the local regulatory teams in CLM, where regulated, for local health authorities’ submission in line with Marketing launch plans
5. Maintain registration databases and ensure accuracy of regulatory approvals
6. Build constructive relationships with the local health authority and/or local regulatory representatives, as applicable, maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio and executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status;
7. Contribute to continuous review and improvement of processes within the country Regulatory Affairs (RA) department to ensure consistent, efficient, and effective practices
8. Contribute to RA team meeting to learn from colleagues, share experiences and best practice
9. Engage Marketing colleagues to strategize new product regulatory pathways, line extensions and changes to currently approved products and actively accelerate launch timelines.

10.Manage interactions with stakeholders and distribution centers as required to ensure product supply is not disrupted.
11. Act as auditee/ SME for regulatory issues in internal and external audits
12. Any other duties as assigned by manager

Essential knowledge and skills:
• Bachelor’s degree in Pharmacy, Medical Science or Biomedical Engineering;
• Excellent and proficiency in English verbal and written communication is required;
• Highly responsible, well-organized, good problem-solving skill and having sense of urgency
• Ability to interpret complex issues and technologies and present them in simple terms to facilitate understanding by others;
• Ability to handle multiple projects and work under stress;
• Achievement-oriented with a high degree of flexibility and ability to adapt to a changing environment.
• Proactive team player, able to take charge and follow-through.

• Bachelor’s degree in Pharmacy, Medical Science or Biomedical Engineering;
• Excellent and proficiency in English verbal and written communication is required;
• Highly responsible, well-organized, good problem-solving skill and having sense of urgency
• Ability to interpret complex issues and technologies and present them in simple terms to facilitate understanding by others;
• Ability to handle multiple projects and work under stress;
• Achievement-oriented with a high degree of flexibility and ability to adapt to a changing environment.
• Proactive team player, able to take charge and follow-through.