Regulatory Affairs Manager

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.

Responsibilities

• 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.
• Provides input for new/revised regulations to BPOM as Abbott or through trade associations.
• Gives input about Abbott positioning and concerns.
• Attends regulation socialization as a member of trade associations.
• Engages in advocacy through associations for concerns that may impact Abbott.
• Participates in engagement activities with BPOM together with trade associations.
• Submits and obtains approval for products in periodic time.
• Collaborates with MKT and Global to prepare registration documents and packaging preparation.
• Reviews PMRA according to regulations.
• Provides input or recommendations for communication materials.
• Updates 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 parts.
• 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.
• Min 10 years' experience in Food Regulatory Environment (Registration Submission, Ijin Khusus, dll).
• Expert in Food Regulation (Indonesia and Overseas).

The base pay for this position is N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Regulatory Operations

DIVISION: AN Abbott Nutrition

LOCATION: Indonesia > Pondok Indah : Wisma Pondok Indah 2

WORK SHIFT: Standard

TRAVEL: No

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott is a multi-national broad-based healthcare company with more than 70,000 employees with operations in 130 countries worldwide and approximately 40 manufacturing facilities. Towards reaching our aggressive goals in Indonesia, Abbott is committed to acquiring and developing the best talent in the industry by providing challenging opportunities in an environment that reinforces individual growth and development, and where the highest degree of integrity, individual initiative, balanced risk taking, entrepreneurial spirit and teamwork are encouraged and rewarded.