Senior Regulatory Affairs Specialist

Abbott; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Abbott in Singapore seeks a Senior Regulatory Affairs Specialist to support global regulatory activities and ensure compliant business processes. The role includes preparing submissions, collaborating across R&D, QA, marketing, and supply chain, and guiding regulatory strategy for new products and line extensions.

The candidate should have a strong regulatory background, excellent communication skills, and the ability to manage multiple projects in a dynamic environment across markets.

Qualifications

• Bachelor’s degree (or equivalent) is required.
• MS in a technical area or MBA is preferred.
• A Ph.D. in a technical area or law is helpful.
• Certification such as RAC is a plus.

Responsibilities

• Ensure compliance with corporate and regulatory policies and SOPs.
• Track regulatory changes and industry trends for impact assessments.
• Lead development of regulatory strategies for new products and market entries.
• Collaborate with R&D, commercial, QA, and supply chain to address regulatory hurdles.
• Execute regulatory tasks and manage key projects to support AN strategy.
• Assist in regulatory SOP development and process optimization.
• Review scientific documentation and regulatory submissions as needed.

Skills

Regulatory knowledge

Cross-functional communication

Analytical thinking

Project management

Attention to detail

Regulatory strategy

Verbal/written communication

Education

Bachelor’s degree

MS in technical area or MBA

PhD in technical area or law (helpful)

Job description

Location Singapore Category Regulatory Affairs

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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® and Glucerna®, to help get the nutrients they need to live their healthiest life.

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

The Opportunity

As the Senior Regulatory Affairs Specialist, provide support for the regulatory department to ensure efficient and compliant business processes and environment. Execute regulatory tasks and play a consultative role by partnering across business functions. Assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products and/or conducting regulatory assessments using worldwide data. Prepare and submit documentation or oversee preparation of documentation needed for registration worldwide. Provide technical leadership to business units.

What You’ll Do

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs.
• Work with markets and relevant SMEs to track emerging legislative changes and industry trends to support impact assessments and appropriate handover processes to cross functional teams.
• Support and/or lead development of regulatory strategies for new product innovations, line extensions and market entry.
• Partner with R&D, commercial, quality assurance, supply chain teams to address technical and regulatory hurdles.
• Execute regulatory tasks and manage key projects critical to support AN strategy to futureproof business needs and changes.
• Assist in Regulatory SOP development and/or review; identify areas for improvement and optimization in regulatory quality systems and processes.
• Depending on specific role, may be involved in various regulatory activities including review of scientific documentation, regulatory submissions and follow-up, evaluation of product and manufacturing changes for regulatory implications, support compliance audits,
• Maintaining annual licenses, registrations, listings and patent information, review and approval of label changes, advertising and promotional content, and providing regulatory input to product safety issues and product recalls.

Requirements

• Bachelor’s degree (or equivalent) is required.
• Preferred area of focus in science (biology, chemistry, nutrition, dietetics, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields. M.S. in a technical area or M.B.A. is preferred.
• A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• 6-7 years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area.
• 4-5 years of experience in a regulated industry (e.g., infant and adult specialized nutritionals, medical/pharmaceutical products).
• Regulatory knowledge of regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes.
• Knowledge of GxPs (GMPs, GLPs, GCPs).
• Knowledge of principles and requirements of promotion, advertising and labeling.
• Specialized nutrition, food and pharmaceutical regulations, especially in Asia is an added advantage.
• Strong communication skills with the ability to communicate effectively verbally and in writing, communicate with diverse audiences and personnel, and work with and negotiate with people from various disciplines, organizations, and cultures.
• Ability to follow scientific arguments, identify regulatory scientific data needs and, with supervision, solve regulatory issues and define regulatory strategy.
• Ability to evaluate various technical alternatives.
• Strong attention to detail.
• Ability to create and manage multiple project plans and timelines.
• Ability to think analytically; organize and track complex information.

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.

Job Id 31164945 LocationSingapore Medical surveillance Not Applicable Division AN Abbott Nutrition Travel Not specified Additional Location Significant work activities Not Applicable

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Abbott is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Employment decisions are based on qualifications, merit, and business needs.

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We provide reasonable workplace accommodations. U.S. residents only: To request accommodation, please call 224-667-0340 or email [e-mail].

Abbott is committed to pay equity and transparency. Compensation is determined using objective, job-related, and gender-neutral criteria in compliance with applicable laws and local regulations.