Regulatory Operations Associate II

An exciting opportunity has arisen for a Regulatory Operations Associate II to join a global biopharmaceutical company based in West London. A very patient-focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.

Job Responsibilities:

• Preparing a variety of routine and non-routine Word and PDF formatting, including utilising Document Processing supporting tools for submission-ready documentation.
• Performing filing and data retrieval functions as directed, or in conjunction with departmental SOPs.
• Supporting current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
• Interfacing with project managers, regulatory product managers, and/or content authors to discuss routine and non-routine documentation, preparation, and content.
• Participating in submission planning meetings to become familiar with the submission priorities.
• Performing workflows and procedures regarding document tracking, indexing, retrieval, and dissemination of regulatory agency submissions as defined by Regulatory Operations management.
• Carrying out project tasks under the direction of senior colleagues; providing the status of their ongoing projects and Document Processing activities to the manager when required.
• Assisting or providing training to others on software tools used and educating authors on Document Processing procedures and submission ready requirements.
• Leading routine projects, attending project meetings, and taking guidance from senior colleagues in making decisions
• Participating in cross-functional projects.

Skills and Requirements:

• A BA, BS, or MSc with relevant experience in a regulatory document processing function.
• Relevant experience, including electronic document management systems, global regulatory systems, or other experience directly related to Regulatory Operations.
• 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.

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 Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

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

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