Senior Regulatory Affairs Specialist
vor 5 Monaten
Description
Kenvue is currently recruiting for:
**Senior Regulatory Affairs Specialist (Skin / Essential Health Regional Franchise) (M/F/d)**
This position reports into the Senior Manager Skin / Essential Health and is based at Neuss, Germany.
**Who We Are**
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you Join us in shaping our future-and yours.
***
**What You Will Do**
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 Skin / Essential Health franchise.
Key Responsibilities***
- Manages and coaches a team of regulatory professionals.
- Evaluates and coordinates the regulatory deliverables for cosmetic & 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 Skin &/or Essential Health Franchise.
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.
- 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).
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.
- Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts
Back up activities
- Represent the Senior Manager Skin / Essential Health as delegate on request
**Qualifications**:
**What We Are Looking For**
Essential knowledge and skills:
- Relevant Bachelor's Degree or higher
- Expertise across a broad spectrum of Regulatory classifications including Cosmetics & Commodities
- solutions throughout the product lifecycle.
- Solid understanding of regulatory/medical/safety/quality requirements in the mark
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