Hobson Prior is seeking a Senior Regulatory Affairs Specialist with a strong understanding of regulatory frameworks and product development in the consumer healthcare industry. This role requires excellent communication skills, strong organisational abilities and a results-driven mindset. The successful candidate will be responsible for managing new product registrations, ensuring compliance with local regulations and providing regulatory input to product development teams.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Provide regulatory guidance on local requirements to product development teams.
• Assess the quality of preclinical and clinical documentation for submission filing to comply with local Health Authority requirements.
• Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitor the progress of the regulatory authority review process.
• Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
• Ensure that all products comply with local regulatory and quality system requirements.
• Review and approve promotional materials for assigned local products.
• Support internal and external audits and inspections in collaboration with quality function.

Key Skills and Requirements:

• Excellent knowledge of regulatory frameworks and product development.
• Strong communication and interpersonal skills.
• Ability to work under pressure and manage time effectively.
• Proficiency in English.
• Relevant Bachelor's Degree or higher.
• Broad knowledge of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices.
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance.

For more information, please contact Henry LeLacheur.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly please select Contact me at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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