Senior Regulatory Affairs Specialist

About the role

Abbott Nutrition is hiring a Senior Regulatory Affairs Specialist in Singapore to support its regulatory department. The role ensures efficient and compliant business processes, executes regulatory tasks and plays a consultative role by partnering across business functions, preparing and submitting documentation for product registration worldwide and providing technical leadership to business units.

Key responsibilities

• Ensure compliance with corporate and divisional policies, procedures and regulatory SOPs.
• Work with markets and stakeholders to track legislative changes and industry trends, supporting impact assessments and handovers to cross-functional teams.
• Support or lead the development of regulatory strategies for new products, line extensions and market entry.
• Partner with R&D, commercial, quality assurance and supply chain teams to address technical and regulatory hurdles.
• Execute regulatory tasks and manage key projects supporting the AN strategy.
• Assist in developing and reviewing regulatory SOPs and improving regulatory quality systems.
• Depending on the role: review scientific documentation and submissions, evaluate product and manufacturing changes, support compliance audits, maintain licenses, registrations, listings and patent information, approve label and promotional content, and give input on product safety and recalls.

Required profile

• Bachelor's degree (or equivalent); preferred fields include biology, chemistry, nutrition, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering or medicine.
• M.S. or M.B.A. preferred; Ph.D. in a technical area or law helpful.
• Certification such as RAC is a plus.
• 6-7 years of regulatory experience preferred, though related experience in quality assurance, R&D, scientific affairs or operations may be considered.
• 4-5 years of experience in a regulated industry such as infant and adult nutritionals or medical/pharmaceutical products.

Required skills

• Knowledge of regulatory requirements, guidelines, policies, standards, agency structures and processes.
• Knowledge of GxPs (GMP, GLP, GCP).
• Knowledge of promotion, advertising and labeling requirements.
• Specialized nutrition, food and pharmaceutical regulations, especially in Asia, are an advantage.
• Strong written and verbal communication, negotiation and analytical skills, attention to detail, and proficiency with computers.