Head of Regulatory Affairs – Abbott – Jakarta, ID

Regulatory Affairs & Strategic Direction
Anticipate, track and assess Indonesia regulatory & policy trends in the nutritional environment that may drive/impact regulation, policy and legislation.
Lead, navigate and execute regulatory strategy on ground to drive regulation change in market and key areas of interest, including stakeholder mapping, KOL engagement plans and other initiatives.
Build new relationships and expand existing relationships with key regulatory stakeholders in Indonesia to anticipate potential challenges to business and identify opportunities to build/grow the business.
Stakeholder Engagement
Identify, develop & maintain positive relationships with relevant stakeholders while building Abbott credibility & trust as a leader in Nutrition & Science, as well as support the Abbott position and Abbott Nutrition International (ANI) – Indonesia LRP
Develop processes to monitor and utilize emerging regulatory, policy and intelligence information, including details on key networks/influencers, regulatory agencies, KOLs and other stakeholders.
Manage key relationships within trade associations, advocate for Abbott’s position on key topics, and when necessary, take leadership role on key issues relevant to the business
Support ANI Snr Leaders on interactions with relevant external stakeholders, KOLs and government agencies.
Regulatory Support
Build & manage a committed, accountable organization. Recruit, develop and mentor regulatory professionals ensuring an effective succession plan
Managing a Regulatory Affairs & Quality Assurance team, ensuring timely registration/approval of current and future portfolio
Manage partnerships with internal customers by ensuring timely updates on regulatory, policy and legislative changes that may negatively impact the business or provide opportunity to expand/grow business
Preservation of Compliance
Ensures compliance to SOPs relevant to market practices and required ethical standards.
Ensure compliance with Abbott Nutrition guidelines, local regulations for the different territories and codes of practice
Maintenance of Knowledge Base
Maintain a high level of product knowledge through familiarity with medical and scientific literature for all Abbott Nutrition products and the pipeline portfolio.
Develops and maintains updated knowledge of applicable current global/regional nutritional regulations and guidelines (e.g. Codex).
Attendance of relevant external international and local regulatory/ /quality conferences to maintain subject matter knowledge
Managing People
Motivate, develop and reward team a high-performance culture, aligned with HR policies and practices

Education Requirements
Minimum: Bachelor’s degree in food technology/nutrition/pharmacy/science related field.
Preferred: Physician, Medical Degree, PhD, Master’s degree or advanced education in food technology/nutrition/pharmacy/science.

Requirements/Experience
A minimum of 10 years prior experience in Regulatory, R&D, Medical, Quality or related area, preferably in nutrition.
Experience interfacing with government regulatory agencies and proven skill at developing and implementing successful regulatory strategies
Strong communication skills to effectively present regulatory information in writing and verbally to management, KOLs and government agencies

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