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European Head of Regulatory Affairs

2 months ago

Folkestone, Kent, United Kingdom Church & Dwight Full time
{"Key Responsibilities": "

Liaison & Communication:

  • 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.

Regulatory Oversight:

  • Direct the development and management of regulatory documents, including technical files and dossiers.
  • Provide guidance on EU regulatory strategy and compliance for medical device and pharmaceutical products.

Project & Audit Management:

  • Organize and manage project assignments related to investigational, new, and marketed products.
  • Assist in third-party and competent authority audits.

Regulatory Intelligence:

  • Act as a liaison with government agencies and trade associations to gather and anticipate regulatory changes.
  • Communicate the impact of emerging regulations to the business and global partners.
", "Skills & Attributes": "
  • Strong leadership skills with a focus on results and business.
  • Ability to exercise sound judgment, manage multiple projects, and work cross-functionally.
  • Excellent communication and presentation skills.
  • Competent in dealing with regulatory authorities.
  • Experience working in a matrix organization.
  • Fluency in a second language (ideally French) is preferable.
", "Education & Experience": "
  • Awareness of legislation impacting the manufacturing of European C&D products, including Cosmetic, Medical Device, Pharmaceutical, Electrical, Food supplement, and Detergent.
  • Proactive in advising the business on Regulatory and Quality regulations.
  • Previous experience in Medical Device essential; experience in additional sectors such as cosmetic and/or pharmaceutical drugs is beneficial.
  • Knowledge of regulations such as MDR, MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO 9001).
", "About the Role": "

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.

", "Company Overview": "

At Church & Dwight, we believe that when we strive for growth, anything is possible. We are a company that genuinely cares about our people, our products, our consumers, and the environment.

We have a unique, informal culture that champions courage, determination, and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership.

", "Why Work with Us": "

United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.

", "What We Offer": "

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Join us and play a crucial role in shaping the future of regulatory affairs in Europe.

", "Contact Information": "

Please submit your application through our website.

", "Language": "English"}