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 Position: ?BI Developer- Contract
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
