Regulatory Affairs Senior Specialist

Regulatory Affairs Senior Specialist

Lo que hacemos

En Kenvue, nos damos cuenta del extraordinario poder del cuidado diario. Sobre la base de más de un siglo de herencia y arraigados en la ciencia, somos el hogar de marcas icónicas, incluidas NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® y BAND-AID® que ya conoces y amas. La ciencia es nuestra pasión; El cuidado es nuestro talento.

Quiénes somos

Nuestro equipo global está formado por ~ 22.000 personas brillantes con una cultura laboral en la que cada voz importa y cada contribución es apreciada. Nos apasionan las ideas, innovación y comprometidos con la entrega de los mejores productos a nuestros clientes. Con experiencia y empatía, ser un Kenvuer significa tener el poder de impactar a millones de personas todos los días. Ponemos a las personas en primer lugar, nos preocupamos ferozmente, nos ganamos la confianza de la ciencia y resolvemos con coraje, ¡y tenemos oportunidades brillantes esperándote! Únase a nosotros para dar forma a nuestro futuro y al suyo. Para obtener más información, haga clic en aquí.

Role reports to:

法规事务副总监

Ubicación:

Asia Pacific, China, Shanghai, Shanghai

Lugar de trabajo:

Totalmente in situ

What will you

Position Summary

·          Develop problem-solving strategies which drive efficiency within the project teams, ensure product compliance and deliver high-quality submissions per project timelines for both NPD and LCM projects. (e.g. ANDA/NDA, variations, renewals etc.)

·          Build strategic regulatory insights in Big-health industry, provide innovative regulatory strategies/direction to the business for relevant selfcare products and seek potential regulatory innovation opportunities to accelerate & optimize the registration pathway.

·          Provide thorough assessment to establish the feasible registration pathway of pipeline/projects /claim innovation with excellent execution to ensure fast introduction and enrich selfcare portfolio ((OTC, Medical Device, Health Food, etc.)

·          End to end regulatory lead for submission strategy & dossier process also post submission communications ensure success registration & product speed to market.

·          Establish and maintain good connections with regulatory authorities (Provincial FDA, NMPA, CDE, CFDI, etc.) to ensure effective product registrations. Support on Self care external engagement to positively shape the favorable regulatory environment.

·          Proactively partner with internal business stakeholders (local, regional, global) to develop of innovative regulatory strategies & excellent execution to ensure that regulatory requirements are incorporated upfront and project risks are understood and mitigations in place.
Required Qualifications

Required Minimum Education:  Minimum Bachelor Degree in Pharmacy, Biology, Chemistry or related Life Sciences.

Required Years of Related Experience:  Preferred minimum 3 years’ experience in Regulatory Affairs.

Required Knowledge, Skills and Abilities:Experience and knowledge of regulatory requirements relevant for the categories relevant for the company.

Skillful written and fluent spoken in English and Mandarin.

Competencies: Agile and efficient thinking; Able to think business strategically; excellent execution； Risk analysis/management;.

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