Deskripsi Pekerjaan

Job Brief :

Responsible for coordination & preparation of regulatory submissions and strategies to the Indonesian Food and Drugs Authority (BadanPengawasObatdanMakananRepublik Indonesia (BPOM RI) in a timely and professional manner.

Job Responsibility

Manage the final product submissions, negotiate and communicate effectively with regulatory authorities to obtain timely product approvals
Ensure the availability to the affiliate of all relevant registration dossier on new and existing products (filing and archiving) in a secure place within company premise
Advise on promotional materials and campaigns to ensure adherence to Badan POM regulations
Provide project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
Develop & maintain regulatory knowledge of relevant international regulations

Persyaratan

Requirement

Male / Female at his or her late 35 or early 45
Bachelor’s / Master degree in Pharmacy from reputable university
Minimum five years of experience in pharmacy company would be preferred
Strong people leadership experience
Execellent in written and verbal english commuication skills and computer literacy
A thorough understanding of the drug registration processing at BPOM and have extensive experience in the regulatory field
Show excellent communication, inter-personal skills, and personal influence
Has effective time management skill and able to set priority in task planning
Be able to resist any influence which would hamper decision making