Pondok Indah, IDN
16 days ago
Regulatory Affairs Manager
**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 association + Analysis the product until assessment the formula + Recommendation for next action + Review implication of new or revise regulation to the ANI's product + Provide assessment + Input to the RPI system + Giving input for new/revise regulation to BPOM as Abbott or through trade association + Giving input about Abbott positioning and our concern + Attend socialization of regulation as member of trade association + Doing advocacy through association for concern that may impact Abbott + Engagement activity to BPOM together with trade association + Submission and approval Product in Periodic Time + Together with MKT and Global to prepare document registration and packaging preparation. + Review PMRA according to regulation + Giving input or recommendation for communication materials + Update the progress and the trend + Initiate and arrange meeting with KOL and BPOM + Submit Petition with appropriate supporting data + Review and assess formula + Give input for business decision- Helping business/sharing regulation to related part + Participate with other department + Sharing 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) An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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