Regulatory Affairs Associate
Hours: 40 hours
Location: Maastricht or Heerlen Office - Hybrid 2 or 3 days in the office.
Duration: 12 months
Responsibilities may include the following and other duties may be assigned.
- Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD).
- Submissions are produced with electronic publishing tools in compliance with document management standards.
- Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing, and implementing plans, and providing input to systems designs.
- Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
- Prepares, submits, tracks, indexes and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Required Knowledge and Experience:
- Bachelor?s Degree in a life science, clinical research studies or engineering.
- Initial years of experience in an industry-related environment.
- Entry level position (0-3 years? experience) and willing to get things done.
- Preference Regulatory knowledge, (ie Regulatory submissions, Regulatory affairs, global regulatory) and ICH Guidance.
- Regulatory experience within a medical device or pharmaceutical environment is desirable.
Skills:
- Autonomy and proactivity organized knowing how to prioritize and plan.
- Interpersonal communication.
- Client focus, results orientated,
- Flexibility to work in different scenario.
For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to rurayayi@achieva.co.uk
- Agency: Achieva Group Limited
- Reference: RU-165
Website: Achieva Group Limited
- Posted: 29th August 2023
- Expires: 26th September 2023
