Regulatory Consultant - Maidenhead, United Kingdom - Proclinical

Tom O´Connor

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Tom O´Connor

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Description
Proclinical are recruiting a Regulatory Consultant for a biotech organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.


Responsibilities:


  • Guide the regulatory evaluation of commercial/medical resources working in collaboration with commercial and medical teams and external regulatory associates.
  • Offer regulatory due diligence examinations in collaboration with business development when needed.
  • Handle relationships with distribution associates and regulatory affairs consultancies to guarantee business goals are met.
  • To assist with successful product launches in central eastern Europe and middle east, you will offer countryspecific methodical regulatory guidance to country managers.
  • Other duties may be assigned to this role.

Key Skills and Requirements:


  • Educated to a degree level in a scientific or similar field.
  • At least 5 years of experience of countryspecific European Regulatory needs for novel products in latestage development as well as post approval.
  • Familiarity with middle east product registration would be beneficial.
  • Preferably an amalgamated mix of large company best practices and smaller company adaptability and acquaintance.
  • Expertise on European regulatory affairs and affiliated needs.
  • Past involvement in interfacing with national competent authorities within Europe.
  • Capable and willing to work within a highvisibility, fastpaced setting.
  • A flexible individual with a high attention to detail.
  • Able to resolve issues with solid analytical capabilities.
  • Works well in a team as well as able to take own initiative.
  • Fluency in the English language.
  • Communication skills both verbally and in writing.
  • A result oriented individual with the ability to meet deadlines and work well while under pressure.
  • A motivated individual with the ability to plan and prioritise workload.


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.

LI-PD1

Regulatory

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