The Associate Regulatory Affairs specialist is responsible for the
registration document(s) procurement, preparation and coordination and
will support the coordination, development and/ or execution of CMC
regulatory registration activities in accordance with the site
commercialization strategies and global regulatory plans.
Key Activities
- Registration document(s) procurement, preparation, coordination
submission and archival
- Coordinates legalization and delivery of registration documents
following the instructions provided in the request.
- Maintains tracking and organization of documentation, including
uploading in CSD tool or other document repository.
- Supports the Site Regulatory CMC Team in the compilation and
preparation of marketing application and post-approval submissions as
needed.
- Maintaining and optimizing relevant databases, tracking systems and
document management processes to support the licenses.
_EDUCATION_ & Experience-Bachelor/Master?s degree (Regulatory, Life
Sciences, Biotechnology or related discipline)-Candidates MUST have
GMP site experience , with some sort of reg experience Candidate needs
to have Regulatory filings at least-Excellent written and verbal
skills-Knowledge of Good Manufacturing Practices (GMP) and good
documentation practices-Strong written and oral communication
skills-The applicant should have basic knowledge regarding CMC
sections of a Marketing Application (BLA,
-NDA, IND, NDS)-Solid working knowledge on document management systems
such as Documentum.
For more information and a full job spec contact Nicola on (phone
number removed) or email your CV in the strictest confidence to Senior Associate Regulatory Affairs Specialist
The Associate Regulatory Affairs specialist is responsible for the
registration document(s) procurement, preparation and coordination and
will support the coordination, development and/ or execution of CMC
regulatory registration activities in accordance with the site
commercialization strategies and global regulatory plans.
Key Activities
- Registration document(s) procurement, preparation, coordination
submission and archival
- Coordinates legalization and delivery of registration documents
following the instructions provided in the request.
- Maintains tracking and organization of documentation, including
uploading in CSD tool or other document repository.
- Supports the Site Regulatory CMC Team in the compilation and
preparation of marketing application and post-approval submissions as
needed.
- Maintaining and optimizing relevant databases, tracking systems and
document management processes to support the licenses.
_EDUCATION_ & Experience-Bachelor/Master?s degree (Regulatory, Life
Sciences, Biotechnology or related discipline)-Candidates MUST have
GMP site experience , with some sort of reg experience Candidate needs
to have Regulatory filings at least-Excellent written and verbal
skills-Knowledge of Good Manufacturing Practices (GMP) and good
documentation practices-Strong written and oral communication
skills-The applicant should have basic knowledge regarding CMC
sections of a Marketing Application (BLA,
-NDA, IND, NDS)-Solid working knowledge on document management systems
such as Documentum.
For more information and a full job spec contact Nicola on (phone
number removed) or email your CV in the strictest confidence to
We need : English (Good)
Type: Permanent
Payment:
Category: Others
