Regulatory Affairs Specialist (Indonesia)

Johnson & Johnson is recruiting a Regulatory Affairs Specialist based in Indonesia

The Regulatory Affairs Specialist, Medical Device, Indonesia, is a member of the local Regulatory Affairs department, responsible for actively contributing to the regulatory compliance of medical devices under their responsibility. The position is responsible for providing input into the global regulatory strategy and identifying country requirements for successful regulatory fillings such as New Products/New Registration, Variation and Renewal. Supports and responsible for product life-cycle management and ensures compliance of product portfolio with country health authority regulations. Reviews technical and regulatory documentation for regulatory filings e.g. product submission and approval. The Regulatory Affairs Specialist also has responsibilities for maintaining and executing activities in accordance with the Quality Management System within the country.

Key Responsibilities :

1. The Regulatory Affairs Specialist will be a member of the local regulatory affairs department within Johnson & Johnson Medical, Indonesia, with responsibility for regulatory aspects of the assigned product portfolio/s

2. Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Indonesia.

3. Request the documentation required for registration submissions for new registration, line extension, change to registered products/variants and product renewal

4. Preparation of submissions to the local health authority for new products, variations, renewal to existing products in line with marketing launch plans,

5. Maintain departmental and source company databases of regulatory approvals, and other related tracking

6. Promo material and labeling review as required.

7. Build constructive relationships with the local health authority by compiling and submitting high quality submissions and providing prompt responses to questions

8. Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio

9. Contribute to continuous review and improvement of processes within the Indonesia Regulatory Affairs (RA) department to ensure consistent, efficient and effective practices across the team

10. Establish communication with marketing colleagues to share information about new products, variation, renewal and review timelines for product approvals.

11. Support internal, external audits and functional regulatory work processes

12. Support requests from marketing and customer related to regulatory database and license.

Qualifications :

• Bachelors degree from any major

• Familiarity with the regulatory systems and product registration requirements in Indonesia; preference more than 2 years;

• Excellent verbal and written communication skills - proficiency in written and oral English is required;

• Ability to interpret complex issues and technologies and present them in simple terms to facilitate understanding by others;

• Demonstrated ability to handle multiple projects; exposure to Project Management

• Knowledgeable in using business applications, such as excel and word processing, presentation, and electronic mail

• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor;

• Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required;

• Enthusiasm for Regulatory Affairs: achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment;

• Proactive team player, able to take charge and follow-through