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Assistant Regulatory Manager, Cheltenham
Client:
Location:
Job Category:
Other
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EU work permit required:
Yes
Job Views:
1
Posted:
04.06.2025
Expiry Date:
19.07.2025
Job Description:
Our client is a global leader within Footcare, with a portfolio across medical devices, cosmetics, orthotics, and personal care. They are looking to add an Assistant Regulatory Manager to their team.
The Assistant Regulatory Manager will facilitate the delivery of NPD/EPDs to global markets, oversee the rollout of existing products, and ensure regulatory compliance. The role involves supporting regulatory planning across innovation and providing SME knowledge on core dossier requirements.
Responsibilities include:
* Supporting registration and regulatory requirements across multiple markets to enable global pipeline delivery.
* Working within the Global Regulatory Footcare team to optimize processes and streamline efficiencies.
* Preparing and reviewing regulatory documents for product registration.
* Maintaining up-to-date knowledge of regional and national regulations.
* Participating in product development and marketing projects for local and international launches.
* Maintaining regulatory databases and records.
* Providing training on regulatory practices.
* Developing regulatory strategies for successful product registration and variations.
* Collaborating with partner functions for market-specific data and timelines.
* Building relationships with local regulatory contacts and partner functions.
The Requirements include:
* Honours degree in a scientific field or equivalent experience.
* At least 2 years of relevant regulatory experience, including dossier/technical file creation and global registrations.
* Experience with quality management systems (ISO 13485).
* Knowledge of regulatory classifications and legislation, including Medical Devices, Cosmetics, REACH, or Biocides.
* Understanding of global regulatory environment and dossier requirements.
* Experience in preparing and submitting dossiers, variations, and renewals.
* Knowledge of product development regulations and guidelines.
* Ability to work independently and deliver high-quality results under pressure.
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