Job title: Regulatory Affairs Data Manager
A small pharmaceutical company focused within Gastroenterology and Hepatology and based in Middlesex are seeking a Regulatory Affairs Data Manager. This individual must have experience within XEVMPD and IDMP data. This role is office-based 3 days per week.
- Day to day oversight and management of Regulatory Affairs (RA) Core Data, XEVMPD and IDMP data
- Maintaining current Subject Matter Expertise regarding RA data legislation, guidelines and requirements, interpreting impact and communicating intelligence internally
- Conducting assessments of data requirements and developing plans to mitigate risks so that compliance with RA data legislation is achievable
- Partner with Associate Director, RIMS to ensure that RA Systems are compliant with RA data legislation, including IDMP requirements
- Creation and maintenance of RA data maps, processes and governance to support consistent use of RA data
- Continuous improvement of RA data models and processes
- Bachelor's degree in Computer Science, Business Administration, or related technical field or equivalent experience.
- Significant (5-8 years) business systems/business process experience, with a minimum of 5 years experience in a Regulatory Affairs/Regulatory Operations environment
- In depth knowledge and understanding of regulatory data processes, legislation and standards including XEVMPD, ISO IDMP, EMA SPOR, Pharmacopeia, Standard Terms/Referentials, CMC and regulatory dossier lifecycle, MedDRA codes, etc.
- Familiarity of GxP, and ideally Annex 11 and 21 CFR Part 11 computerized systems
- Excellent interpersonal skills and stakeholder management skills
- Self-motivated and able to work both autonomously and collaboratively within a team
Salary and benefits:
A highly competitive salary, annual bonus, pension scheme, private healthcare and wider benefits are on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org