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