Regulatory Affairs Consultant

Discover International
Closing date
14 Oct 2020

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Contract Type
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Our client, a mid size international pharmaceutical company with a exciting pipeline of development projects and an established portfolio of marketed products, requires a Regulatory Affairs Consultant to support their largest therapeutic area for an initial period of 6 months.
Please note this role is inside IR35. The role will be completely remote initially but should restrictions ease then it could be that 2 days per week would be onsite in London.
The job responsibilities include the following;
  • Planning and leading regulatory CTA submissions across Europe as well as other submissions such as variations for marketed products and applications such as new indications or MAAs
  • Knowledge of Small Molecule/NCE products.
  • Support team in preparation for Brexit and documentation changes necessary.
  • Update department management on project status of regional strategies and tactics, procedures and practices, with a focus on the EU
  • Manage the preparation and submission of complex regulatory submissions for assigned products in line with regional regulatory requirements.
  • Knowledge of regulatory requirements and anticipate, assess and communicate changes in regulatory information to project teams and senior management in a timely manner
  • Contact with Regulatory Authorities for assigned product(s) and territories
Should you be interested to know more please apply by clicking the link below.
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