This position will be located in Jakarta.
About the Role:
As Jr. Regularoty Affairs & Phamacovigilance Manager you will support marketing and manufacturing by administering regulatory support to the business during the life cycle of the products within the prescribed POM regulation, head office and corporate policy with the objective to obtain legal registration of New Products / line extension/ change technical data, labeling, design, leaflet and maintain the exist products. You will also act as a link between companies and regulatory authorities, to ensure that pharmaceutical products are manufactured and distributed in compliance with appropriate legislation.
What you will be doing:
1. Support/Contribute to Marketing Company
Facilitate marketing and sales in obtaining approval of certain marketing and/or sales activities from regulatory point of view in order to ensure compliance to the appropriate regulatory requirements
2.Education and Socialization
Counsel/coach all department (especially Finance and HR Dept) on GDPm in order to widened and increased their knowledge, in order to implement Good Distribution Practices (GDP)
3. Training Support
Conduct GDP related training sessions for all department related with distribution process (especially Finance and HR Dept.) in order to support distribution activities and comply to GDP.
4. Coordination
Provide consultation and advise of the status of product registration and regulatory approach related product issues at the monthly coordination meeting with marketing and manufacturing in order to provide current information on product registration status.
5. Corporate Product Database
Monitor product regulatory database, supervise data entry and update of registration status and other required information in order to ensure updated local database of product according to the world wide corporate SOPs
6. Drug/Product Registration
Coordinate with HQ, PGM , marketing and related departments to administer regulatory documents of new product or product/ price changes, line extensions and/or other regulatory changes including label/packaging; review and prepare documents completion and compliance to local regulation, submit and follow up to BPOM in order to obtain approval on product registration.
7. Import Product
Administer regulatory approval of new products, line extensions and/or other regulatory changes including label/packaging for imported product and prepare all necessary documentation in order to assure smooth business continuity and compliance.
8. Clinical Research
Assist clinical research function to obtain clinical trial and import license for clinical trials in order to ensure compliance to the appropriate regulatory requirements.
9. New Product Launch Preparation
Participate in the development of artwork and promotion material (database, production, reviewing related artwork and promotion material) to ensure compliance with regulation in order to ensure on schedule preparation of the new product and compliance.
10. Product Intelligence
Conduct competitor product intelligent activities in regulatory arena to obtain specific information as the basis for negotiation and discussion with the authority during the evaluation process of the related product(s).
11. Medical Information
Monitor and provide up to date information on rules and regulations from the Directorate General of POM to the management in order to ensure all related departments are kept abreast the rules and regulations and act accordingly.
12. Quality Assurance
Supporting / Helping Head Department in Quality Assurace tasks, such as handling product quality complaint and product recall (reporting, investigation, documentation)
13. Authorized Responsible Pharmacist
Company License as Pharmaceutical Wholesaler with the detail Job Description as per attached file in order to ensure the distribution of products comply to Good Distribution Practices
14. Others
Supporting / Helping Head Department on her other responsiblities, such as:
a. Compliance: help preparing and giving presentation for new employee
b. Legal: help reviewing agreement between SI and third party
c. Managing Data protection
This position will be located in Jakarta.