Regulatory Specialist

JOB DESCRIPTION:

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and products in diagnostics medical devices nutritional and branded generic medicines. Our 109000 colleagues serve people in more than 160 countries.

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 Specialist
This position works out of our UAE location in the Abbott Nutrition Division

About Nutrition
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 including Similac PediaSure Pedialyte Ensure Glucerna to help get the nutrients they need to live their healthiest life.

As Regulatory Affairs Specialist youll

• Develop and implement regulatory strategy for registration of new products in close collaboration with Medical Sales and Marketing Department considering 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

What Youll Do-

Product registration launch and maintenance

• Development of regulatory strategies for placing on the market per business needs (assessment of formulas advice on product category and claims handle tactics and submission timing verification of label claims setting mitigation plans etc.)

• Negotiate with regulatory authorities as applicable 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

• Monitor emerging issues and identify solutions

Responsibility includes:

• African countries and expansion

• Other as defined by business needs/opportunities

Scope is region wide regulatory direction for:

• Product development and support to develop most rapid successful strategy for registration to market products to meet business objectives

• Administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions.

• Managing/leading a team of people including reports in different locations

• Leading role in internal and external (Trade Associations KOLs etc.) meetings and calls

• Interfaces with a variety of management levels including senior management on significant matters

• Provides technical leadership to business units

What Youll Do-

• 4-6 year- experience in a regulated 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.

• Excellent written English and communication skills

• Highly developed project management skills

• Excellent problem-solving skills and solution-oriented mindset

• Business acumen

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.

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The base pay for this position is

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

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