AD, Regulatory Affairs CMC

AD, Regulatory Affairs CMC

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:

VP 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 Associate Director, Regulatory Affairs CMC, is responsible for developing regulatory strategies and providing guidance to product development and commercial teams.

Key Responsibilities

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, annual reports, supplements and variations and responds to regulatory information.

• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.

• Ensure the timely submission of INDs, NDAs, amendments, and supplements for assigned  products/projects.

• Develops strategies for CMC agency meetings. Manages preparation for agency meetings, and content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.

• Manage products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.

• Represents CMC regulatory affairs on cross-functional teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.

• Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization.

• Develops, implements, and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC.

• Serve as the Regulatory Affairs representative on project teams; manage the progress of projects by providing direction, solutions, and feedback to the teams.

• Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization, may include formal supervisory responsibilities

What we are looking for

Required Qualifications

• Minimum of 5 years of experience in Regulatory Affairs.

Desired Qualifications

• A minimum of a Bachelor’s degree is required, pharmacy, Chemistry, Biology or Pharmacology.

• Experience with INDs, NDAs, ANDA and leading health authority meetings.

• Experience working with industry counterparts and trade association committees and task groups is preferred.

• Experience working in a matrix environment. OTC industry experience preferred

• Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others

• Strong oral and written communication skills.

それは何ですか

$166,600.00 - $235,200.00

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。