Regulatory Affairs Associate

Umbilical Ltd
13 Nov 2017
16 Nov 2017
Contract Type
Full Time

- Assists with the preparation of regulatory filings for submission to UK and international health agencies in the areas of new drug development, marketing applications and approved product support.
- Assists with or executes the electronic publication and submission of documents to the MHRA.
- Compiles materials required in submissions, license renewal and annual registrations.
- Monitors and improves tracking/control systems.
- Participates in Regulatory interaction with internal departments and external customers.
- Monitors and maintains awareness of the UK and global regulatory environment, assessing impact to regulatory affairs practices and procedures.
- In collaboration with external pharmacovigilance vendor, maintains on-site pharmacovigilance files and records and ensures their completeness and readiness for external audit or inspection.
- Assists the Chief Medical Officer as needed to ensure appropriate level of Company oversight of pharmacovigilance vendor.

Qualificaions and Experience:

- Bachelor degree in the life sciences, chemistry, pharmacy, or other related course of study from accredited college or university; advanced degree is preferred.
- Minimum two years of relevant experience in pharmaceutical, biological product, or medical device Regulatory; will consider candidates with experience outside of regulatory affairs but with transferrable skillsets.
- Excellent written and verbal English communication skills.
- Ability to manage multiple projects, set priorities and meet deadlines.
- Keen attention to detail
- Strong ability in the use of writing and publishing computer applications; sufficient IT comfort to be able to learn new software specific to the regulatory affairs functions.
- Excellent skills in MS Office: Word, PowerPoint, Excel, Outlook.