JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people\xe2\x80\x99s health. We\xe2\x80\x99re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

Career development with an international company where you can grow the career you dream of.

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Regulatory Affairs Manager-Gulf

This position works out of UAE location in Abbott Nutrition Division

About Nutrition Division

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands \xe2\x80\x93 including Similac\xc2\xae, PediaSure\xc2\xae, Pedialyte\xc2\xae, Ensure\xc2\xae, Glucerna\xc2\xae and ZonePerfect\xc2\xae \xe2\x80\x93 to help get the nutrients they need to live their healthiest life.

As Regulatory Affairs Manager-Gulf you\'ll-

Develop and implement regulatory strategy for registration of new products, in close collaboration with Sales and Marketing Department, taking into account business strategy and regulatory requirements, ensure maintenance of in-line products and support new business opportunities in countries under responsibility

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:

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 Responsibilities

Regional responsibility includes:

Gulf (UAE, Kuwait, Oman, Bahrain, Qatar), Yemen, Iran as defined by business needs/opportunities

Position Accountability / 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

Required Qualifications-

Bachelor\'s degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) preferred.

Preferred Qualifications-

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.

Excellent written English and communication skills

Highly developed project management skills

Excellent problem solving skills

Understanding the business

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

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: United Arab Emirates
Dubai : Ubora Tower2

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable

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