Senior Associate - Regulatory Affairs

Senior Associate - 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:

Director Regulatory Affairs

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 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

それは何ですか

$100,300.00 - $141,600.00

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。