AdresseAbbott 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®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.
Primary Overview:
- Monitor and partner with stakeholders to influence and shape Regulatory environment.
- Proactively monitor emerging regulatory issues and develop a plan of action to mitigate adverse impacts to Abbott Nutrition (ANI) business.
- Manage key regulatory programs, particularly those with unique regulatory strategies and position
- Work closely with commercial and marketing teams to understand and support their business plans.
- Engage and collaborate with ANRA, Affiliate QA, R&D, Medical Affairs, Legal and Corporate Affairs to protect our brands and launch new products.
- Plan and execute an effective regional regulatory strategy that will support timely registration/approval of new and innovative ANI products in Singapore.
- Analyzing and identifying regulatory requirements against project needs.
- Communicating registration requirements prior to and during R&D cycle to ensure technical dossiers are effectively presented to the regulatory agencies for timely registration/approval of new products.
Major Responsibilities:
- Build good relationship and dialogue while earning trust and credibility with KOLs and key influencers in regulatory agencies and other stakeholders.
- Maintain keen awareness of Regulatory environment to help share RA environment and assess challenges and solutions and communicate to appropriate stakeholders to ensure product compliance and support product launches.
- Deploy proven communication skills to effectively present scientific information in writing and verbally to management, KOLs and government agencies.
- Participate and contribute to selective scientific and trade organizations to shape our positions on innovation, safety and benefits of nutrition products based on sound scientific evidence and to promote food and nutrition standards and regulations.
- Plan and implement regulatory activities including development, presentation, and review of required regulatory documents to support new product registrations / addition in hospital formulary.
- Ensure requirements for effective approvals and registrations are met in a timely manner.
- Review and maintain regulatory documents and files (including product label, promotional materials and registration packages); record product filing, approvals, and registration activities for new products.
- Execute plans, complete tasks according to priorities set by manager, align work with business goals, and align actions with agreed strategies.
- Assure promotional and marketing materials compliance.
Supervisory/Management Responsibilities:
- Direct interaction with RA functions including Strategic Area, Regulatory Innovation and Regulatory Science and other functions such as R&D, Medical Affairs, Quality, Legal and Corporate Affairs.
- Develop and manage regulatory professionals
Requirements:
- Bachelor’s Degree in Nutrition/Science related field. Masters degree is advantageous.
- Minimum 10 years of experience in Regulatory Affairs in nutrition/food industry
- Good understanding and working experience in different regulatory environment in Singapore
- Good knowledge and understanding of scientific aspects of nutritional products including safety and benefits
- Proven track record of successful registration filing process of new nutrition products including novel petitions
- Ability to manage and prioritize multiple projects
- Ability to understand, compile and synthesize complex scientific data and articulate safety and benefits of ANI products
- Effective communication, presentation and persuasion skills
- Adaptable in cultural and political diversity
- Strong team player
- Capacity to learn and challenge status quo
- Self-motivated
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.
