Regulatory Affairs Specialist

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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。

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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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Kenvue is recruiting for a Regulatory Affairs Specialist (Self Care)

Reporting to:

Senior Manager / Manager Regulatory Affairs (Self Care)

Location: Reading, UK

Job Description

Job purpose

The Senior Regulatory Affairs Specialist is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.

• Evaluates and coordinates the regulatory deliverables for drugs, dietary supplements & medical devices, within their geographical and/or brand area of responsibility
• Develops effective partnerships with R&D, Franchise (Marketing) and local regulatory colleagues. 
• Assists in the preparation of dossiers and submission packages for the registration and maintenance of products throughout their whole lifecycle
• Represents the Regulatory Affairs function as appropriate within the Self Care Franchise.
• Support regulatory activities for European procedures as appropriate and reclassification initiatives.
• Provide regulatory support to policy, external engagement, and issue management within the Need State of responsibility and participate in process, simplification & culture-building activities within own team and across enterprise as required.
• Co-responsible for driving alignment of key processes, ways of working and simplifications across the Global and Regional Regulatory Self Care team.
• Responsible for meeting compliance requirements within team such as SOP trainings, audits etc.
• Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties.
• Partner with other critical functions to execute plans to address crises and other sensitive issues.
• Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.

Essential duties and responsibilities

The Roles & Responsibilities include:

Regulatory Strategy

• Works with local and regional regulatory colleagues to develop global and/or regional regulatory

strategies, coordinating regulatory actions and results and develops global/regional dossiers to

support local review processes.

• Organizes materials from preclinical and clinical studies for review and assists in the review process.
• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
• Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings.
• Tracks the status of applications under regulatory review and provides updates to the regulatory team
• Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at regional level.

Regulatory Compliance

• Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
• Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
• Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions
• Ensures that the enterprise Regulatory systems are accurate and fully maintained
• Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally
• Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives
• Support internal and external audits and inspections in collaboration with quality function

Regulatory Advocacy

• Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) and maintains information resources.
• Supports in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant). 

Team Management:  

• Provides technical and leadership development as appropriate. 
• Monitors progress of applications of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties. 

Specific requirements

• Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
• Works with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit.

Other features of the job

• Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice.
• Applies organizational understanding and awareness in decision making.
• Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.

Back up activities

Represent the Senior Manager/Manager Regulatory Affairs (Self Care) as delegate on request

Job Requirements

Essential knowledge and skills:

• Relevant Bachelor's Degree or higher 
• Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices
• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory

solutions throughout the product lifecycle.

• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
• Proficiency in English

Core competencies

• Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
• Strong interpersonal skills; able to build effective personal networks internally and externally.
• Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
• Strong organizational and time management skills with an ability to work under pressure.
• Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced, dynamic,

Results-driven environment.

• In-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross functional business partners to make informed business decisions and create and execute business strategies. Ability to represent RA function on cross-functional teams and governance forums. 
• Able to work effectively in a multi-cultural, highly matrixed organization
• Experience in cultivating and leveraging strategic networks and partnerships
• Proficiency in English

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