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Senior Regulatory Consultant

3 months ago

Uxbridge, United Kingdom Proclinical Full time
Proclinical are recruiting for a Senior Regulatory Consultant - Oncology to join a pharmaceutical organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.

Responsibilities:

  • Guide the development of regional regulatory documents and meetings rendering to GRT methods.
  • Cooperation share regulatory information and implications with the GRT staff on an ongoing basis and offer advice on regional considerations.
  • You will advise the GRT on regional considerations in developing method guaranteeing the regional requirements are well outlined and executed in cooperation with pertinent regional shareholders.
  • Execute product linked regulatory methods, regulatory affairs procedures and action planning rendering to national legislation and regulatory needs.
  • Discuss and guarantee alignment f regional management before GRT method decisions.
  • You will document and discuss details and results of regulatory agency interactions to GRT and pertinent sr. management.
  • Offer managerial leadership and direction to allocated team allowing suitable prioritisation of resources to accomplish objectives.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Regulatory expertise Regulatory knowledge in regional legislation.
  • Familiarity operating with policies, process and SOPs.
  • Acquaintance with national legislation and guidelines linking to medicinal products.
  • Comprehension of the regional regulatory processes for CTAs, MAs, post approval alterations, extensions and renewals.
  • Comprehension of drug development scientific/technical brilliance.
  • Expertise on and prior involvement with regional regulatory setting in pertinent product area and development stage.
  • Understanding of regulatory actions, touch points and how they affect projects and procedures.
  • Capable of resolving issues and develop a course of action leading to a beneficial result.
  • Cultural awareness and sensitivity to complete outcomes both regional country and global borders.


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

Proclinical Staffing is an equal opportunity employer.

Regulatory