Hobson Prior are looking for a RA Officer to join a brilliant pharmaceutical organisation on a permanent basis. Our Client is focused assist in ensuring the safe and effective use of medical solutions by providing regulatory compliance services.

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

Key Responsibilities:

• Managing the constitution of MAs and post-MA files.
• MA file preparation in terms of administrative and/or pharmaceutical information.
• A follow-up on MA applications, answering questions from administrations, and collecting the required documents.
• Follow-up on pending applications and export registration files.
• Filing of MA files.
• Management of paper and computerized marketing authorization copies.
• Establishing, drafting, filing, and monitoring regulations: modules for new MA applications, variations, MA transfers, and risk assessments.
• Developing, validating, and distributing packaging materials and product information.
• Regulatory and scientific application preparation (clinical trial authorizations, ATUs, importation applications).

Key Skills:

• Understand the issues pertaining to the area of responsibility or management you are responsible for.
• Adapt well to organizational change.
• The ability to speak and write English in a professional and operational manner.
• Having the ability to write reports and briefing notes.
• Having the ability to work collaboratively in a demanding environment.
• Provide support to the teams for the registration procedure by the locals.

Requirements:

• A pharmacist with a Master's degree in health law or regulatory affairs.
• Doctoral degree specializing in health law or regulatory affairs.
• An engineer with a specialization in regulatory affairs.
• A Master 2 in regulatory affairs would be advantageous.
• It is necessary to have knowledge of the following areas: EU, EMEA, Latin America, Asia, and the United States.

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.