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Senior Regulatory Affairs Specialist
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Proclinical is working with an innovative global healthcare company that is seeking a Senior Regulatory Affairs Specialist to be based in Singapore on a permanent basis. 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).
Job 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 labelling, 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 and Requirements:
- Fluency in Mandarin
- 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.
- 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.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mandy Fang on +65 3159 1467 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
R1215238 | EA13C6865
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