Senior Regulatory Manager

  • Permanent
  • Runcorn, Cheshire
  • Posted: 12th October 2020
  • Salary: £67500 - £72500 per annum
  • Duration:
  • Reference: BBBH6607
  • Industry:
  • Location: Runcorn, Cheshire
  • Start Date: ASAP
  • Skills:

Koura, currently working in partnership with E3 Recruitment are an international leader in the development, manufacture and supply of fluoroproducts that play a fundamental role in enhancing everyday lives. A highly innovative manufacturing company part of the larger organisation, Orbia, who currently have operations in 41 countries and commercial activities in over 110.

As a Senior Regulatory Manager, you will be a key member of the Quality Leadership Team, responsible for overall leadership and management of all pharmaceutical/GMP regulatory activities for Koura’s downstream business unit. Working closely with the Quality Director and site/business leaders to translate business strategy & goals into strategic and operational regulatory plans and ensure that the company’s activities meet all appropriate GMP regulatory requirements. Collaborating effectively with internal and external customers/stakeholders to build and sustain strong partnerships, foster a learning/continuous improvement culture and create value whilst always keeping patient safety as a top priority.

The company is one of the world’s leading chemical manufacturers operating to GMP, being the largest global producer of the specialist pharmaceutical products 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;

  • The Senior Regulatory Manager will be required to design, develop and execute regulatory strategies and plans that ensure Koura Downstream business activities meet all relevant pharmaceutical & GMP regulatory requirements
  • Monitor and assess future pharma regulatory & GMP requirements to determine the impact and formulate the most effective strategy for the business
  • Keep abreast of changing pharma regulatory needs and expectations in order to support Koura business development in new products, services and markets globally
  • Senior Regulatory Manager will be providing strategic direction for all GMP regulatory activities supporting new product & service development
  • Oversee and ensure efficient processes for global registrations and post market compliance
  • Manage and maintain all existing Koura GMP regulatory dossiers and documentation
  • Work closely with key medical & pharmaceutical customers to support their regulatory processes, activities & requirements
  • Senior Regulatory Manager will direct and oversee the review and approval of marketing communication materials
  • (As a member of the Quality Leadership Team) contribute to defining, managing and improving quality policies, processes, systems and procedures to achieve and maintain world class quality performance

To be successful in this position as Senior Regulatory Manager deep subject matter knowledge of all aspects of regulatory and legislative requirements is essential together with:

  • Minimum – Degree in life sciences, engineering or quality assurance (advanced degree preferred)
  • A formal qualification or certification in medical / pharma / quality will be an advantage
  • 10+ years’experience in a regulated medical device/diagnostic industry incorporating more than 3 years in a regulatory capacity will be essential in this position
  • Experience of successfully delivering regulatory approval for new medical / pharmaceutical products and processes
  • Technical competence in a broad range of regulatory & GMP topics, g. quality assurance, quality control, analytical techniques, quality IT systems, good documentation practice / data integrity, change control, deviations & CAPA management, validation
  • Excellent communication skills, verbal, written and electronic
  • Strong influencing and rational persuasion skills

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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