Regulatory Affairs Manager Abbott Laboratories Dubai

A Regulatory Affairs Manager-Gulf at Abbott Nutrition Division will develop and implement regulatory strategy for registration of new products. This is done in close collaboration with Sales and Marketing Department, taking into account business strategy and regulatory requirements. The role holder will ensure maintenance of in-line products and support new business opportunities in countries under responsibility.

Responsibilities of Regulatory Affairs Manager

• Influence, monitor and implement new regulations in countries under responsibility to support business maintenance and growth.
• Develop a network of relevant regulators, key opinion leaders and industry peers to support and influence.
• As ANRA representative in Emirates Authority for Standardization and Metrology (ESMA), ensure internal interaction with relevant SMEs and engagement with relevant partners to influence upcoming GSO Standards applicable across GCC (Gulf and Saudi Arabia).
• Develop and supervise regulatory professionals as appropriate.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

What you’ll do as Regulatory Affairs Manager

• Development of regulatory strategies for registration approval of 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 regulatory authorities during the review process to ensure registration 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.
• Monitor emerging issues and identify solutions.
• Approval of labels, advertising and promo materials ensuring alignment with local regulations, Codes of Conduct, SOPs, etc.

External Engagement

• Establish and maintain good working relationships with all involved regulatory and other institutions.
• Establish and maintain relations with KOLS (individual meetings, conferences, congresses).
• Assess and communicate impact of relevant global regulations/standards in local market.
• Developing/maintaining of the Operating Local Procedures and all related Quality documentation.

Management of crisis situations

• 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.
• Ensure compliance with all relevant statutory requirements and internal procedures.
• Management and development of regulatory staff as appropriate.

Supervisory Management

• Regional responsibility includes:Gulf (UAE, Kuwait, Oman, Bahrain, Qatar), Yemen, Iran as defined by business needs/opportunities.

Position Scope

Scope is region wide regulatory direction for:

• Product development and support to develop most rapid successful strategy for 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.
• Individual is recognized as an industry expert and resource in regulatory affairs.
• Individual is able to work independently and in from different location from manager, peers, etc.
• Interfaces with a variety of management levels including senior management on significant matters.
• Provides technical leadership to business units.

Eligiblity Criteria

Following is the eligibility criteria for the role of Regulatory Affairs Manager – Gulf at Abbott Laboratories:

• Bachelor’s degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) preferred.
• 3-4 years experience in a regulated industry (e.g., medical products, nutritionals).
• 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Job Skills

• Excellent written English and communication skills.
• Highly developed project management skills.
• Excellent problem solving skills.
• Understanding the business.

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