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.
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
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.
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 email@example.com