Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

私たちがしていること

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。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~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。 私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々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、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

Vice President Regulatory Affairs NA

Location:

North America, United States, New Jersey, Summit

勤務地:

ハイブリッド

あなたがすること

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.

それは何ですか

$242,250.00 - $342,000.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

Kenvueは機会均等雇用者であることを誇りに思っています。人種、肌の色、宗教、性別、性的指向、性同一性、年齢、出身国、または保護された退役軍人の地位に関係なく、すべての資格のある応募者は、能力に基づいて雇用の検討を受け、障害に基づいて差別されることはありません。