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.