Kenvueは現在、以下求人を募集しております。
Regulatory Affairs Senior Specialist私たちがしていること
私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。
Who We Are
私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。
Role reports to:
法规事务副总监場所:
Asia Pacific, China, Shanghai, Shanghai勤務地:
フルオンサイトあなたがすること
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;.
障害のある個人の方は、宿泊施設のリクエスト方法について障害支援ページを確認してください。
