Regulatory Affairs Consultant

Hobson Prior are seeking a RA Consultant to join a high-quality biopharmaceutical services on a permanent basis.

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

Key Responsibilities:

• You will lead and joins relevant meetings to promote realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.
• Partner with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from appropriate supplier lines across both HA and EC submission and translation processes.
• Motivates global submission management strategy and activities for assigned protocols.
• Collaborate with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required.
• Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
• You need to build a network of industry colleagues through relationships formed during project engagements or through other industry experience.
• Accountable for the organisation of translations for core documents required for submission.
• Support and leads global team efforts to guarantee high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
• Manages the compilation for core package build, contributing to CTA and authoring documentation as required.
• Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
• Converse with relevant SMEs the interpretation of dossier requirements.

Requirements:

• You will have strong computer skills.
• You should be fluent in English along with the local language.
• You should be educated to a university degree level in Life Sciences.
• You must have a minimum of 2 years' experience in Regulatory Affairs and Clinical Research in Pharma or CRO.
• Previous experience working with a multinational team, focusing on numerous issues under tight deadlines.
• Have a detailed understanding and proven execution of CTA process globally.

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.