Job Scope and Responsibilities:
1. Supports regulatory compliance for marketed products by means of a correct and timely handling of all
regulatory activities on his/her site.
2. Manage regulatory activities link to change controls for his/her site including update of CMC files
3. Supports product licenses maintenance and site registration
4. Ensures the role of regulatory expert for all regulatory topics and projects on his/her site
1. Supports batch release by following submission and approval to ensure the product
regulatory compliance in his/her sites(s)
2. Ensures that the CMC dossier is in line with manufacturing and control procedures on site(s) and with dossiers approved by the Health Authorities
3. Provides regulatory expertise to site projects
4. Assesses and manages Change Control activities with regulatory impact on his/her site(s)
5. Writes CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions
for submission
6. Optimizes the content of CMC dossiers to facilitate the management of future changes
7. Ensure CoA issued for each product will remain comply with the approved and updated
specification in the dossier
8. Supports Marketing Authorizations worldwide (territory extensions, renewals, site registrations and transfers….) by writing the corresponding CMC documents/dossiers and colleting GMP related documents from his/her site(s)
9. Consolidates regulatory activities in a planning tool
10. Ensures the regulatory surveillance on his/her specific field of competencies and
communicates the appropriate information to his/her site(s)
11. Provides results or regulatory indicators applicable to his/her site
12. Implement the appropriate company tools tonhage all his/ her activities
13. Contributes to site inspections and audit
14. Review and sign off RSO related documents such as SOPs or technical reports
15. Responsible for accurate completion of all master certificate of analysis
16. Acts as change of control coordinator
17. Actively involved in continuous improvement in his/ her work area
18. Implement HSE practice in the work place
19. Perform evaluation of Product Quality Review (PQR) on yearly basis
Qualifications and Requirements :
1. Hold Pharmacist profession degree
2. Minimum have 1 year experience as Regulatory Officer or similar
3. Having broad knowledge GMP, local pharmaceutical regulation, analytical methodology and product transfer
4. Having broad knowledge of pharmaceutical manufacturing process
5. Demonstrated and recognized capacity to perform scheduling and monitoring the execution
6. Demonstrated and recognized to perform analytical thinking and pragmatic approach
7. Good knowledge and literacy of microsoft office
8. Detail, process oriented and performance focus
9. Willing to work in a contractual basis for 12 months
#Li-Sea
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
https://halokerja.id connects jobseekers and recruiters by accurately matching candidate profiles to the relevant job openings through an advanced 2-way matching technology. While most job portals only focus on getting candidates the next job, Shine focuses on the entire career growth of candidates.
