Regulatory Systems Strategist

5 days ago

Tiverton, Devon, United Kingdom Mundipharma Full time

Mundipharma is a global healthcare company seeking a highly skilled Regulatory Affairs & Systems Data Manager to join our team in Cambridge. As a key member of our regulatory affairs function, you will be responsible for developing and implementing strategies for regulatory systems, ensuring compliance with relevant regulations.

Responsibilities:
  • System Strategy: Develop a comprehensive system strategy that meets the needs of Mundipharma and complies with regulatory requirements.
  • RIM System Maintenance: Oversee the implementation and maintenance of the RIM system, including routine maintenance, system validation, and integration with other systems.
  • External System Support: Lead a team responsible for providing external regulatory system support, including managing relationships with vendors and stakeholders.
  • Regulatory Data Governance: Ensure the accuracy, integrity, and accessibility of regulatory data, including management of data quality, data governance, and data security.
  • Training and SOPs: Develop and maintain training programs and standard operating procedures (SOPs) for regulatory staff, ensuring they have the necessary skills and knowledge to perform their roles effectively.
Requirements:
  • Experience: Proven experience in regulatory operations, data, and system management, preferably in a pharmaceutical or biotechnology industry.
  • Knowledge: Excellent understanding of regulatory processes, dependencies, and risks, as well as familiarity with relevant regulations and guidelines.
  • Skills: Strong analytical and problem-solving skills, attention to detail, and ability to work independently and as part of a team.
What We Offer:
  • Competitive Salary: £60,000 - £80,000 per annum, depending on experience.
  • Benefits Package: A competitive benefits package that includes flexible benefits options.
  • Professional Growth: Opportunities for professional growth and development, including training, mentorship, and career advancement.

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