offerta salvata in my Randstad

ra specialist a SIENA

luogo di lavoro
siena, toscana
Infermieristica, farmacia, medicina
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offerta salvata in my Randstad


For major chemical and pharmaceutical company we are looking for a RA Specialist.

Main activities:
-Work in project teams with an assigned CMC or Franchise Regulatory Manager on CMC related regulatory activities for his/her assigned projects
- Attend project team meetings and provide CMC related regulatory guidance to other areas of RA, Tech Ops, Quality, and Commercial Operations
- Write and edit Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards
- Review and/or co-author CMC related IMPD/IND documentation
- Assist CMC or Franchise Regulatory Managers with responses to CMC related health authority comments and questions
- Life cycle management for licensed products, in the US, Europe and other major Regions, including regulatory impact assessments and preparation of CMC documentation for variations and other post licensure submissions
- Assist RA CMC and/or RA Franchise Managers with planning of Health Authority meetings and Health Authority briefing books

- Degree in related scientific discipline (natural, pharmaceutical,medical, archival or information technology)

- Excellent knowledge of written and spoken English

- At least 3 years’ experience in RA or related discipline with knowledge of regulatory procedures and requirements
- Ability to manage plan and manage assignment independently
- Demonstrated ability to work and draft documents in a fast paced environment
- Strong organizational skills and attention to detail
- Flexible with respect to prioritization of daily tasks and projects according to internal and external influences
- Ability to work in multifunctional teams
Lingua: Inglese

I candidati ambosessi (L.903/77) sono invitati a leggere l’informativa sulla privacy (art.13, D.Lgs.196/03).
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