Regulatory Manager, Abbott Nutrition International

Location: Israel, Tel Aviv

Primary Job Function:

• Develop and implement regulatory strategy for registration and pricing of new products, in close collaboration with Medical, Sales and Marketing Department, taking into account business strategy and regulatory requirements
• Ensure maintenance of in-line products and support new business opportunities
• Influence, monitor and implement new regulations to support business maintenance and growth
• Interface with outside regulatory agencies and trade associations and provide executive management with regulatory strategy
• Develop a network of relevant regulators, key opinion leaders and industry peers to support and influence policy dialogue

Core Job Responsibilities:

Product registration, launch and maintenance

• Development of regulatory strategies for registration approval including novel ingredients as per business needs (assessment of formulas, advice on product category, handle tactics and submission timing, verification of label claims, setting mitigation plans, etc.)
• Negotiate with different regulatory authorities during the review process to ensure approval
• Provide regulatory support to commercial division in all areas pertaining to product life-cycle management and new product development and introduction
• Ensure implementation of new regulations within legal deadlines
• Assess formulations to ensure compliance with regulations
• Approval of labels, advertising and promo materials ensuring alignment with local regulations, Codes of Conduct, SOPs, etc.
• Utilize technical regulatory skills to propose strategies on complex issues
• Monitor emerging issues and identify solutions

External Engagement:

• Develop a network of relevant regulators, key opinion leaders and industry peers to support and influence regulatory environment in alignment with business model.
• Analyze/negotiate documents/positions put together as AN and within Trade Associations for current and upcoming regulations and assess/influence impact for ANI business to be used for local outreach
• Assess and communicate impact of relevant global regulations/standards in local market
• Establish and maintain relations with KOLS (individual meetings, conferences, congresses)
• Monitor emerging issues and identify solutions

Management of crisis situations/quality events

• Oversee system to ensure that product safety issues and product-associated events are reported as needed
• Represent Regulatory Affairs in product recall and communication process in countries under responsibility

Management of RA budget

Supervisory/Management Responsibilities

Responsibility includes Israel RA team - Management and development of the team

Position Accountability / Scope

Scope is region wide regulatory direction for:

• Product development and support to develop most rapid successful strategy for registration and reimbursement approval to market products to meet business objectives
• Administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions. 

• Must assure that all deadlines are met and provide effective leadership
• Individual is able to work independently and in from different location from manager, peers, etc.
• Completed work is reviewed from a relatively long- term perspective for desired results. 

• Managing/leading a team of people

• Leading role in internal and external (Trade Associations, KOLs, etc.) meetings and calls
• Individual is recognized as an industry expert and resource in regulatory affairs.
• Interfaces with a variety of management levels including senior management on significant matters
• Provides technical leadership to business units

Minimum Education and Experience/Training Required

• Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) preferred.
• 4-6 years of experience in a regulated nutritional industry (e.g., medical products, nutritionals).
• 3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 
• Native local language and fluent English language
• Highly developed project management skills
• Excellent problem-solving skills
• Understanding the business