Lowongan Regulatory Staff (Medical & Cosmetic) di PT Tnp Maternity And Baby Trading

Responsibilities

• Deliver a compliant Indonesia Consumer, health, health devices, supplement, and clothing products business
• Lead local registration strategy and planning for new product development to support business objectives
• Willing to be a PJT (Penanggung Jawab Teknis)
• Ensure a qualified registration dossier is prepared and meeting with the most current requirements in timely manner
• Ensure all relevant regulatory systems and databases are maintained up to date
• To stay updated with the upcoming changes in regulatory legislation and guidelines and define impact to business
• Negotiate and take a lead in driving regulatory bodies on registrations of new products, variations and renewals. Take any necessary actions in order to accelerate the approval
• Build and maintain close relationship with registration authorities and other relevant organizations/bodies.

Qualifications

• Graduate with degree (Bachelors/Masters) in Pharmacy (S1 Farmasi) (Registered pharmacist with Ministry of Health is preferred)
• Have a minimum 1 year of experience in product registration (consumer products, supplements, medicinal, clothing products) and dealing with related government agencies, i.e.: BPOM, Kemenkes
• Knowledgeable with related regulations of product registration (consumer products, supplements, medicinal, clothing products) and corresponding activities (BPOM, Kemenkes)
• Able to clearly present information to non-technical teams through the spoken word
• Able to use a realistic reason in solving problems, even when dealing with emotional topics
• Proficient in English- both written and oral
• Proficient in Computer systems