Regulatory Specialist

Abbott; Dubai; On-site; AED 120,000 - 200,000; Full time

Job summary

A global healthcare leader in Dubai is seeking a Regulatory Affairs Specialist to develop and implement regulatory strategies for product registration within the nutrition division. The role involves ensuring compliance with regulations, negotiating with regulatory authorities, and providing critical support for product life-cycle management. The ideal candidate will have 4-6 years of experience in a regulated industry and strong communication and project management skills.

Qualifications

• 4-6 years experience in a regulated industry, preferably in medical or nutritional products.
• 3 years of experience in regulatory or related fields is preferred.
• Excellent written English and communication skills.

Responsibilities

• Develop and implement regulatory strategies for product registration.
• Negotiate with regulatory authorities for approval.
• Ensure compliance with new regulations.
• Provide support for product life-cycle management.

Skills

Excellent written English

Project management

Problem-solving

Business acumen

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, nutrition 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, recognition as a great place to work in dozens of countries, and a company that is best for diversity and inclusion.

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 worldwide rely on our leading brands including Similac, PediaSure, Pedialyte, Ensure and Glucerna to get the nutrients they need to live their healthiest life.

Regulatory Affairs Specialist you’ll

• Develop and implement regulatory strategy for registration of new products in close collaboration with Medical Sales and Marketing Departments, 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.

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, handling tactics and submission timing, verification of label claims, setting mitigation plans).
• 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.
• 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 the 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.

Qualifications

• 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.

The base pay for this position is N/A.