Proclinical Staffing

Regulatory Process Manager - QMS

Expiring today

Location
Slough, England, Berkshire
Salary
Negotiable
Posted
08 Jan 2021
Closes
22 Jan 2021
Ref
34871
Contact
Keri Marshall
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

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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