Regulatory Specialist

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 109,000 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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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