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.
• Engages in regulation discussions with government and associations.
• Analyzes the product until assessing the formula.
• Provides recommendations for next actions.
• Reviews implications of new or revised regulations on the ANI's product.
• Provides assessments.
• Inputs to the RPI system.
• Gives input for new/revised regulations to BPOM as Abbott or through trade associations.
• Provides input about Abbott's positioning and concerns.
• Attends socialization of regulations as a member of trade associations.
• Advocates through associations for concerns that may impact Abbott.
• Engages in activities with BPOM together with trade associations.
• Submits and approves products in periodic time.
• Collaborates with MKT and Global to prepare document registration and packaging preparation.
• Reviews PMRA according to regulation.
• Provides input or recommendations for communication materials.
• Updates the progress and trends.
• Initiates and arranges meetings with KOL and BPOM.
• Submits petitions with appropriate supporting data.
• Reviews and assesses formulas.
• Provides input for business decisions, helping business/sharing regulations with related parties.
• Participates with other departments.
• Shares knowledge with regulators.

Requirements

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