Job Brief :
Responsible for coordination & preparation of regulatory submissions and strategies to the Indonesian Food and Drugs Authority (Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI) in a timely and professional manner.
- 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
- Age 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
- Excellent in written and verbal english communication 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
If you feel that you can meet the qualification and up for the challenge, please send your complete resume and current color photograph by clicking button bellow
PT Mersifarma TM, named "Mersi" in short, was established in 1997. The founders of Mersi came from different fields of expertise: health, pharmacy, business, and sosio-economics; and with their pioneering vision and professional expertise, the foundation of Mersiconsituted from a strong desire to endeavour in the manufacturing of medicines needed for large segments of the population. Mersiinitially focused on manufacturing of medicines to combat Neuro-Psychiatric, Psychosomatic and Mental Health Diseases, but the need for a much large extension and augmentation became apparent. Today other important areas of healthcare are also catered for at Mersi and they include - Internal Medicine, Pulmonary Diseases, Obstetrics-Gynaecology, Neuro-surgery, Ear-Nose and Throat Diseases, Dentistry, and the urgently needed advanced antibiotic therapeutic agents. Dedicated to the highest level of scientific excellence, Mersi has maintained stringent product quality checks and we are committed to the highest standard of ethics and integrity.
All Mersi products have been upheld by strict professional standards, resulting in Mersi's impeccable reputation for being known to qualityas :Membuat obat Ekivalen Riset Standar Internasional (in Bahasa Indonesia) or Manufacturing (of) drugs Equivalent (to) International Standard Research.
VISION AND MISSION
Mersi as leading pharmaceutical industry in home country and abroad based on universal International standards
To provide and distribute quality medicine, evenly and adequately available at affordable price to society at large to improve public health level in Indonesia and International community