Senior Associate - Regulatory Affairs

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

Role reports to：

位置：

工作地點：

你會做什麼

The Senior Associate of Regulatory affairs is responsible for ensuring compliance with regulatory agency regulations, preparing responses to regulatory agencies' questions, and gathering necessary information for submissions:

Key Responsibilities

• Lead the development and implementation of regulatory strategies for new product submissions
• Provide regulatory guidance and support to cross-functional teams
• Prepare and submit regulatory filings to health authorities
• Stay current on regulatory requirements and communicate changes to internal stakeholders
• Conduct regulatory intelligence activities to assess impact on product development
• Lead and manage regulatory activities for a diverse portfolio of products
• Collaborate with regulatory agency personnel to expedite approval of applications and resolve complex regulatory issues
• Develop and implement regulatory strategies to achieve department and company objectives
• Ensure strict compliance with global, regional, and local regulations, policies, and procedures
• Prepare and submit high-quality regulatory submissions and responses to agencies in a timely manner
• Create and monitor detailed timelines for regulatory submissions
• Communicate effectively with key stakeholders on project/product updates
• Contribute to the development of best practices for Regulatory Affairs processes
• Maintain accurate and organized regulatory documentation
• Coordinate and manage reporting schedules efficiently
• Assist in the preparation of comprehensive regulatory reports and presentations
• Ensure adherence to quality and compliance standards in all regulatory activities

What we are looking for

Required Qualifications

• University/Bachelors Degree in a related field
• 4-6 years of experience in regulatory affairs
• Strong knowledge of global regulatory requirements
• Ability to work effectively in a fast-paced environment and manage multiple projects simultaneously
• 4-6 years of experience in handling regulatory data for regulated products such as OTC Drugs, Cosmetics, and Medical Devices
• Proficiency in Word, Excel, PowerPoint, Email, and Internet applications
• Familiarity with Regulatory processes including Drug Listing, IDMP, and Periodic Safety Reporting

Desired Qualifications

• Excellent communication and interpersonal skills
• Strong attention to detail with exceptional documentation skills and problem-solving abilities
• Excellent interpersonal skills with a collaborative and solution-oriented approach
• Ability to multitask and deliver high-quality work under pressure
• Effective communication and stakeholder management skills

對您有什麼好處

這考慮了許多因素，包括工作地點、候選人的技能、經驗、教育水準和其他與工作相關的因素

Kenvue 很自豪能成為一個機會均等的雇主。所有合格的申請人都將根據業績獲得就業考慮，不分種族、膚色、宗教、性別、性取向、性別認同、年齡、國籍或受保護的退伍軍人身份，並且不會因殘疾而受到歧視。