Regulatory Process Manager - QMS

Proclinical has partnered with a large pharmaceutical company in search for a Regulatory Process Manager. This is an excellent opportunity for a talented, independent and self-motivated regulatory professional to join a team that will not only provide you with a wide variety of experience in regulatory projects, it will also give you all the support you need to develop your regulatory career.

Job Responsibilities

• Develop the GRA Quality Management Systems:
• Develop the collaboration to ensure that the GRA Processes are developed in accordance with Business Needs via the leading of adequate GRA Quality Documents committees.
• Develop the collaboration with key stakeholders as PVQA, RAQA and GPS Compliance teams to ensure a smooth interface
• Develop the Regulatory Intelligence to ensure the anticipation of the development of new Processes is in place in relation to new or updated Regulations
• Develop the visibility of the team via powerful communication channels to maximize the impact of the reporting
• Identify the need of creation/review of GRA Processes
• Lead the Support relating to the authoring, review, approval and training of the GRA Processes
• Ensure the appropriate communication with your key stakeholders to promote their adherence
• Escalate any potential issues or difficulties raised during the GRA QDs Committees
• Ensure delivery of trainings and ensure their centralisation and follow-up
• Ensure delivery of relevant communications channels
• Provide technical and regulatory mentorship
• Ensure adequate reporting

Skills and Requirements

• Life Sciences Graduate or Pharmacist, ideally with a post-graduate qualification
• At least 5 - 7 years' experience in the medicines industry
• Experience in writing EU regulatory documents with sound knowledge of the EU medicines Directive associated guidelines
• Proven capability in working on multiple projects and effectively managing time to meeting critical timelines
• Able to demonstrate effective communication skills in dealing with diverse group of stakeholders
• A willingness to support resolving complex issues and driven to deliver results
• Good organisational and analytical skills with the flexibility to work across multiple client projects, with excellent attention to detail
• You will be expected to work independently on a day-to-day basis, whilst integrating into team project work.
• The successful candidate will also be fluent in written and spoken English

To Apply

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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