Regulatory Operations Manager

Proclinical is advertising a vacancy for a Regulatory Operations Manager position with a new global healthcare company. With an extensive pipeline and commercial portfolio across a range of clinical areas, this organisation is offering an exciting opportunity to join their team in Uxbridge. The Regulatory Operations Manager will work with a leading company and have the chance to apply solid project management skills to drive the execution of submissions.

The Regulatory Operations Manager will support the development of documents created for global regulatory submissions. They will collaborate cross-functionally with internal departments and external resources on Regulatory Affairs-related issues. They will also ensure team alignment on submission content plans and be accountable for submission timelines for assigned projects. They will track the progress of all components of the regulatory submission dossier and act as Subject Matter Expert (SME) for producing a dossier that is compliant with required formats and aligns with submission strategies.

Job Responsibilities:

• Leading and driving cross-functional teams focused on the planning and execution of regulatory submissions. This includes anticipating regulatory obstacles, identifying emerging issues, and proactively developing solutions.
• Planning and executing all submissions throughout a product's lifecycle (i.e. early/late development, post-marketing, etc.).
• Leading and facilitating facilitates submission planning meetings to ensure clear communication of the project plan, actions items, risks and decisions to the team.
• Independently managing multiple regulatory submission projects, including the development of submission content plans.
• Ensuring that all regulatory content and information is appropriately tracked, archived, searchable, and accessible.
• Entering and tracking project and submission data in Regulatory Information Management system.
• Working directly with regulatory leads to develop submission content project plans.
• Working directly with publishing colleagues and external third-party vendors to ensure an accurate and quality assembly of submission dossiers.
• Leading and/or participating in department initiatives focused on the improvement of regulatory submission management processes and tools; developing and contributing to new regulatory processes and providing training support as appropriate.
• Contributing to the development of SOPs, Work Instructions (WIs), and training materials required to support regulatory submission-related activities
• Updating internal processes to ensure compliance with health authority requirements and expectations.
• Providing end-user support for eDMS-based applications including conducting requisite training for eDMS users.

Skills and Requirements:

• Bachelor's degree in a related field or an equivalent combination of experience and education.
• A minimum of 5 years of progressively responsible experience in a pharmaceutical, biotechnology, contract research organization (CRO), or another related environment.
• Project Management Professional (PMP) Certification.
• Demonstrable project leadership experience involving the assembly, formatting, compilation and submission of regulatory documents.
• Demonstrable ability to define, and lead the implementation of, process/system improvements related to regulatory submissions.
• Hands-on experience generating, reviewing and formatting documentation for worldwide regulatory submission.
• Demonstrable expertise utilising eDMS applications used for regulated document control, preferably in a pharmaceutical or biotechnology company.
• Extensive experience supporting or administering eDMS based applications used for regulated document control, preferably in a pharmaceutical or biotechnology company.
• Experience managing/overseeing relationships with third party vendors.
• Demonstrable understanding of the CTA framework in Europe.
• 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 Alex Czuprynski at +44 203 869 2329 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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