Senior Regulatory Manager

  • Permanent
  • Runcorn, Cheshire
  • Posted: 15th September 2020
  • Salary: £67500 - £72500 per annum
  • Duration:
  • Reference: BBBH6607
  • Industry:
  • Location: Runcorn, Cheshire
  • Start Date: ASAP
  • Skills:

Orbia Advance Corporation is a Purpose-led company with big aspirations. We are out to advance life around the world while maximizing value to our shareholders, customers and employees. The Company is passionate about the topics that define how people will live and thrive tomorrow: the future of cities, buildings, agriculture, and materials. Orbia Advance Corporation has five business groups which offer innovative solutions across multiple industries including building and infrastructure, data communications, chemicals and more. Orbia Advance Corporation has operations in 41 countries with more than 22,000 employees.

As a Senior Regulatory Manager reporting to the Quality Director, you will provide direction for regulatory affairs programs including new product development, global registrations, advertising and promotional materials, product labelling, post market compliance and adapting to new requirements.

The company is one of the world’s leading chemical manufacturers operating to GMP, being the largest global producer of the specialist pharmaceutical product manufactured across their sites. To maintain their status as a market leader within the sector, this manufacturer has ambitious but stable expansion and investment strategies over the next 5-10 years in which this individual as Senior Regulatory Manager will be key to delivering and facilitating.

Responsibilities of the Senior Regulatory Manager;

  • Balance the sometime conflicting needs and expectations of internal and external customers.
  • Build and develop a high performing regulatory affairs and quality assurance team.
  • Provide strategic direction for new product development compliance strategies.
  • The successful Senior Regulatory Manager will direct and oversee the compliance and quality planning processes with responsibility for strategic and tactical planning processes.
  • Oversee and ensure efficient processes for global registrations and post market compliance.
  • Direct and oversee programme for review and approval of marketing communication materials.
  • Responsible for the customer complaint system.
  • Responsible for managing product failures and appropriate corrective actions.
  • Drive and self-manage working to GMP high standards, within a high hazard COMAH chemical manufacturing plant.

To be successful in this position as Senior Regulatory Manager knowledge of all information systems such as eQMS, LIMS, CDS etc is crucial. Writing and/or review of IQ, OQ and PQs and other validation documents would also be beneficial.

Working for this multi-billion-pound market leading company as a Senior Regulatory Manager means receiving a comprehensive benefits package alongside salary. This including 25 days holiday plus stats, flexible working, 15% pension, private health care and discretionary annual bonus.

Please apply directly for further information.

*No agencies please*

 
 

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