Senior Director, 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：

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你會做什麼

The Senior Director, Regulatory Affairs, is a seasoned regulatory professional with in-depth knowledge of FDA regulatory requirements and guidelines. Responsible for developing and executing regulatory strategies and providing guidance to product development and commercial teams in support of Kenvue’s Self-care product Portfolio. The ideal individual must have proven ability to thrive in a collaborative cross-functional environment, along with strong analytical skills, attention to detail, effective problem-solving abilities, negotiation and strong communication skills.  and adaptability is required for this position

What you will do 

Key Responsibilities

• Provide strategic guidance to the organization in support of creative regulatory strategies for the US and Global Allergy portfolio.
• Liase with the FDA and serve as RA lead for Health Authority meetings for innovation products and marketed products.
• In-dept knowledge and experience with RX-to-OTC Switch
• The ability to influence effectively in a matrixed environment
• Proactively scan and engage in the external environment and provide regulatory intelligence and insights to internal teams to anticipate and prepare for changing regulatory requirements.
• Leverage your knowledge of the consumer healthcare products industry to shape internal product development, claims, and labeling processes such that they are efficient, compliant and fit-for-purpose.
• Interface with senior leaders in business to develop, implement, and maintain policies and standards
• Oversee and provide guidance to the regulatory team approving budgets, strategies, product claims in accordance with internal procedures and external guidelines
• Oversee the technical team responsible for creation and maintenance of Self-care product innovation labeling.
• Develop and maintain procedures for key regulatory processes.
• Set objectives for RA SC team members in alignment with organizational goals and objectives.
• Perform other duties as assigned

What we are looking for

Required Qualifications

• Minimum of 10 years of experience in Regulatory Affairs.

Desired Qualifications

• A minimum of a Bachelor’s degree is required, preferably in a science-related or legal field. Advance degree preferred but not required.
• Experience with INDs, NDAs, ANDA, RX-to OTC Switch and leading health authority meetings.
• Experience working with industry counterparts and trade association committees and task groups is preferred.
• A proactive, big picture strategic thinker who can distill complex scenarios into simplified guidance for internal teams.

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。