Abbott Sr.Specialist Regulatory Affairs in Singapore, Singapore

Accountability / Scope:

  • It is a critical business continuity role and the individual will work with Project teams to ensure timely submissions, approvals which enables business for timely launches.

  • As the professional in the Regulatory Affairs function, the individual will assist in the registration of products by preparing and submitting documentation needed for registration in North Asia (China, Taiwan & Hong Kong).

  • Individual will execute and manage technical and scientific regulatory activities, understand regulations that might impact Regulatory submissions/ launches.

  • Individual shall develop strategic partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions and any deficiencies and develop approach to solutions.

Major Responsibilities:

  • Ensures timely approval of Foods, Infant Milk, Drugs, Functional health Foods for China, Taiwan & Hong Kong. Possess well developed skills in directing development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc …

  • Partner with appropriate teams for successful inclusion of China in to the Central Regulatory Operations Model.

  • Lead regulatory submissions strategy and update strategy based upon regulatory changes

  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

  • Partners with affiliates to support regulatory agency interactions to expedite approval of pending registration.

  • Serves as regulatory liaison throughout product lifecycle.

  • Participates/ Awareness on Affiliates Business plans, project plan, regulatory submission strategy, any risks management.

  • Advises project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

  • Partner with other regulatory functions for smooth project transition and launch.

  • Partner with relevant stakeholders to determine trade issues to anticipate regulatory obstacles

  • Submit and review change controls to determine the level of change and consequent submission requirements

  • Offers country specific regulatory support

  • Assist in SOP development and review

Skills/Experience Requirements

  • Prior experience (5-7 years min) and Bachelor’s degree in nutrition/science related field.

  • Good understanding and working experience in different regulatory environment in multiple countries preferably in China will be advantageous.

  • Proven track record of successful registration filing process of new nutrition products.

  • Knowledge and understanding of formulation & scientific aspects of nutritional products.

  • Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Influence stakeholders on technical solutions.

  • Participates in determining goals and objectives for projects. Establishes and cultivates an extensive network of support to facilitate timely launches.

  • Adaptable in cultural and political diversity.

  • Capacity to learn and challenge status quo.

  • Team player

  • Self-motivated.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com