Responsibilities

As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

Interacts with regulatory agency to expedite approval of pending registration.Serves as regulatory liaison throughout product lifecycle.Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.Serves as regulatory representative to marketing, research teams and regulatory agencies.Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.Doing engagement to involve in the regulation discussion with government and associationAnalysis the product until assessment the formulaRecommendation for next actionReview implication of new or revise regulation to the ANI's productProvide assessmentInput to the RPI systemGiving input for new/revise regulation to BPOM as Abbott or through trade associationGiving input about Abbott positioning and our concernAttend socialization of regulation as member of trade associationDoing advocacy through association for concern that may impact AbbottEngagement activity to BPOM together with trade associationSubmission and approval Product in Periodic TimeTogether with MKT and Global to prepare document registration and packaging preparation.Review PMRA according to regulationGiving input or recommendation for communication materialsUpdate the progress and the trendInitiate and arrange meeting with KOL and BPOMSubmit Petition with appropriate supporting dataReview and assess formulaGive input for business decision- Helping business/sharing regulation to related partParticipate with other departmentSharing knowledge to regulator

Requirements

Minimal Bachelor Food Technology/Pharmacy.Expert in Food Registration, HACCP, Food Standardization, Halal Food, CODEX.Min 10 years' experience in Food Regulatory Environment (Registration Submission, Ijin Khusus, dll)Expert in Food Regulation (Indonesia and Overseas)