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European Head of Regulatory Affairs, Folkestone
Client: Church & Dwight
Location: Folkestone, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: f85030cda2ad
Job Views: 11
Posted: 26.04.2025
Expiry Date: 10.06.2025
Job Description:
Job Description
We are seeking a dynamic and experienced European Head of Regulatory Affairs to join our team. In this role, you will ensure that our products comply with all regulatory requirements across Europe, partnering closely with the European business and liaising with various departments to achieve our strategic goals. You will report to the VP of Regulatory Affairs (US) and lead a team of European Regulatory Affairs personnel.
Key Responsibilities:
* Act as the bridge between UK/EU management and the Quality Business, QA Manufacturing, and Regulatory Departments.
* Ensure effective communication of issues, concerns, and management objectives across departments.
* Develop and manage regulatory documents, including technical files and dossiers.
* Provide guidance on EU regulatory strategy and compliance for medical device and pharmaceutical products.
* Manage project assignments related to investigational, new, and marketed products.
* Assist in third-party and competent authority audits.
* Engage with government agencies and trade associations to monitor regulatory changes.
* Communicate the impact of emerging regulations to the business and global partners.
Skills & Attributes:
* Strong leadership skills with a results-oriented approach.
* Ability to manage multiple projects and work cross-functionally.
* Excellent communication and presentation skills.
* Experience dealing with regulatory authorities.
* Experience working in a matrix organization.
* Fluency in a second language (preferably French) is advantageous.
Education & Experience:
* Knowledge of legislation impacting manufacturing in Europe, including Cosmetic, Medical Device, Pharmaceutical, Electrical, Food supplement, and Detergent sectors.
* Proactive advising on Regulatory and Quality regulations.
* Previous experience in Medical Devices is essential; experience in cosmetic and/or pharmaceutical drugs is beneficial.
* Familiarity with MDR, MDSAP, OTC, EU Reg 1223/2009, and ISO standards (22716, 13485, 9001).
Join our team and play a crucial role in shaping the future of regulatory affairs in Europe. Apply now and lead with us!
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