Regulatory Affairs Consultant

An international staffing and recruiting company is currently recruiting a Regulatory Affairs Consultant to join their office in the UK. This organisation is one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. This is an exciting opportunity to work with a firm dedicated to innovative and dynamic approaches to the changing workforce landscape.

This will be a contract role.

Job Responsibilities:

• Assisting Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, and regulatory authority meeting preparations).
• Providing and maintaining CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead.
• Creating and maintaining product regulatory history documents through IMR/rRISE and appropriately archiving all regulatory documents and agency communications.
• Reviewing regional component of the Global Regulatory Plan and providing input to operational deliverables.
• Ensuring compliance via timely submissions to regulatory agencies.
• Supporting RRL by reviewing promotional materials for commercial activities (ex-US).
• Collaborating with CROs/partners to support site initiation.
• Coordinating the collection of functional documents in support of regulatory applications.
• Participating in GRT to support execution of regulatory strategy.
• Coordinating QC of regulatory documentation (e.g. briefing packages).
• Providing primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages).
• Preparing regulatory packages and cross-reference letters to support investigator-initiated studies.
• Approving drug shipment for the company and Investigator Initiated Studies.
• Completing regulatory forms to support agency communications (E.G. EudraCT).
• Providing regulatory support to Commercial, Medical, and Clinical departments through cross-functional interactions in brand and therapeutic area teams.
• Supporting process improvement initiatives, standards development, and metrics.
• Assisting in template development and maintenance.
• Responding to specific requests from, and communicating relevant issues to, GRT.
• Developing Regulatory Position with teams.
• Actively support regulatory compliance.
• Supporting the development and execution of GRT goals.

Skills and Requirements:

• Relevant experience and/or training and education.
• 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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