Senior Associate Regulatory Specialist

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 Regulatory Specialist is responsible for ensuring compliance with regulatory agency regulations, preparing responses to regulatory agencies' questions, gathering necessary information for submissions, and providing solutions to problems of moderate scope and complexity:

Key Responsibilities

• Lead regulatory submissions for new product approvals and post-approval changes

• Develop and maintain regulatory strategies to ensure compliance with global regulations

• Provide regulatory guidance to cross-functional teams on product development and lifecycle management

• Conduct regulatory intelligence to stay abreast of changes in regulations and guidelines

• Collaborate with regulatory agencies to address inquiries and resolve issues

• Lead and manage regulatory activities for a diverse portfolio of products

• Collaborate with cross-functional teams to develop and implement regulatory strategies

• Review and approve promotional materials to ensure compliance with regulatory guidelines

• Provide guidance and support on regulatory processes such as Drug Listing and Periodic Safety Reporting

• Develop and maintain reporting schedules for regulatory submissions

• Present status updates on regulatory activities to key stakeholders

• Participate in joint company/trade association initiatives and regulatory agency meetings

• Drive continuous improvement in Regulatory Affairs processes and best practices

• Ensure quality and compliance in all regulatory actions

What we are looking for
Required Qualifications

• Bachelor's degree in a scientific discipline or related field

• 4-6 years of experience in regulatory affairs within the pharmaceutical industry

• Strong knowledge of global regulatory requirements and guidelines

• Proficiency in Word, Excel, PowerPoint, Email, and Internet applications

• Strong attention to detail and problem-solving skills

Desired Qualifications

• Experience with regulatory processes such as IDMP and safety reporting

• Excellent communication and interpersonal skills

• Excellent interpersonal skills with a collaborative approach

• Ability to work effectively in a fast-paced and dynamic environment

• 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。