Regulatory Affairs Specialist

An international pharmaceutical organisation is seeking to recruit a Regulatory Affairs Specialist to their office in Romania. This company focuses on developing treatments for conditions where the impact of the medicines can make an immediate and tangible difference. They provide treatments in Neuroscience, Rare Diseases, and other medical sectors. This is an exciting opportunity to work with a globally renowned organisation and bring specialist knowledge and experience to the position.

Job Responsibilities:

• Overseeing operational regulatory affairs activities.
• Interfacing from LOC to European and Global RA, ensuring conformance to national and EU Drug Legislations.
• Maintaining labelling information to internal and external partners.
• Supporting internal Global RA and other R&D departments.
• Providing collaborative support for commercial teams.
• In collaboration with EU strategist, interacting with national health authorities in Romania.
• Ensuring adherence to company standards and local laws.
• Managing and coordinating interactions with Romanian regulatory authorities for national licenses and facilitates interactions by the EU RA strategists in the case of European procedures.
• Acting as the regulatory contact point for local international and global cross functional teams on all regulatory matters.
• Acting as the RA Specialist with primary national regulatory responsibilities for Romania for all product franchise(s).
• Ensuring timely responses to incoming authority requests, incl. timely notification of approvals according to company SOPs.
• Submitting applications to national authorities in Romania in liaison with local, national, and regulatory consultants if applicable, for products approved in the national procedure, and for the national phase for products approved through MRP and DCP, when relevant.
• Providing regulatory advice and assistance to support the Romanian LOC strategy for relevant product franchise(s).
• Ensuring labelling implementation in Romania, such as notifying business teams and updating external websites and compendia in line with internal procedures and external requirements.
• Ensuring that regulatory Romanian requirements are fully represented in discussions at Local, Regional, and Global levels in conjunction with the Regulatory, Quality, and Safety Lead in Romania.
• Providing local support to the EU Regulatory strategists for local submission when necessary in case of specific contact to take with the agency or review of national requirements.
• Supporting QA/Compliance, participate in drawing up and monitoring Company standard operating procedures, as well as checking on their application, in cooperation with superiors.

Skills and Requirements:

• Demonstrable experience in a similar or comparable role.
• Demonstrable education or experience in a relevant or comparable field.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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