Regulatory Affairs Specialist
Hours per week: 40
The Regulatory Management Center is a new regional organization to handle the majority of LOC activities led by senior regional regulatory staff, where they will handle tactical LCM processes (CMC Variations and Labeling Changes) in the region. The Center will be embedded in the AP, EMEA and LA regional organizations, and it will work in close collaboration with the respective LOCs and regional and global departments.
The RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports) and LOC team members (matrix organization).
The responsibility of RMC Submission Management is to lead wide range submission processes for multiple countries, preparing country-specific submission ready dossiers,manage Agency questions when required and ensure post-approval activities to take place for those submissions.
EXPERIENCE AND EDUCATION
* A minimum of a University degree or equivalent by experience
* At least 3 years of regulatory experience in the LOC
* Experience of working in a virtual team and/or global organization would be an asset .
* Previous experience in RA role as Associate, Professional or similar role is of advantage.
* In depth knowledge of local and regional regulations/legislation.
* Experience in working with limited supervision and able to make independent decisions
* Excellent verbal and written communication skills - proficiency in written and oral English
* Cultural sensitivity and ability to work and thrive in a multi-cultural environment.
* Proactive team player, able to take charge and follow-through.
* Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
* Proficient use of technology including RA tracking systems (TrackWise / SPS/MPD) - preferred
The position is located in the LOC of the respective region (EMEA, Asia Pacific and Latin America).No relocation is required
Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones
Occasional international travel (3-5x/year) may be required.
Are you the new Regulatory Affairs Specialist? Apply now online or to speak to Michelle Smit via 020 522 15 88 or m.smit[a]realstaffing.com