Regulatory Affairs Manager

Abbott; Daerah Khusus Ibukota Jakarta; On-site; IDR 300,000,000 - 400,000,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to lead product registration and compliance efforts. This role requires extensive expertise in food regulations, including HACCP and Food Standardization, to ensure timely approvals and adherence to local and international standards. You will collaborate with various teams and regulatory agencies, providing insights and recommendations that shape product strategies and marketing initiatives. If you have a passion for regulatory affairs and a commitment to excellence, this opportunity offers a chance to make a significant impact in a dynamic environment.

Qualifications

• 10+ years of experience in Food Regulatory Environment.
• Expert knowledge in Food Registration and HACCP.

Responsibilities

• Directs product registration submissions and interacts with regulatory agencies.
• Ensures timely approval of new drugs, biologics, or medical devices.

Skills

Food Registration

HACCP

Food Standardization

Regulatory Affairs

Risk Management

Education

Bachelor in Food Technology

Bachelor in Pharmacy

Job description

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).