Regulatory Affairs Manager
- Requires suitable level of experience within a broad range of Regulatory Affairs project with sound knowledge of Indonesia Regulatory Procedures (Drugs/Biologics)
- Responsible for providing to stakeholders and advising clients on strategic regulatory considerations for non clinical and clinical (phase I –IV) product development, study design and such as review of relevant regulatory precedents for evolving standards, product label key massaging and rigorous regulatory review for successful registration.
- Prepared the dossier according ACTD and set up the submission, manage the performance within agreed timeline and budget.
- Maintain excellent communication and collaboration with Global Regulatory/Regulatory team, other stakeholders as well as relevant colleagues from other region/branches.
- Min. Bachellor's Degree in Pharmacy from reputable University (Apothecary Profession)
- Min. of 3 years experience in similar position from pharmaceutical company
- Familiar in dealing with government institution related pharmaceutical business (Kementrian Kesehatan, BPOM)
- Have a strong leadership in managing a team
- Excellent in English both written and oral
- Computer literate
- Can work under pressure, Have excellent attitude, Self initiated
Tutup pada 05/November/2016