...regulatory authorities) on defined matters.
·
Face external audits / inspection, coordinate and communicate with external auditors / inspectors for compliance.
Qualifications
Expertise in regulatory compliance ...
...of Modules-I as per regulatory requirement.
Note: The candidate can work individually.
Regulatary Affairs,dossiers,regulatory documents
Designation: Assistant Manager/Sr..Regulatory Affairs Off...
...Align to a regulatory submission strategy in the clinical development part of the projects.
ORGANIZATION STRUCTURE
Reports to: VP - Clinical development
Relationships (Internal): Manager & all other ...
JOB DESCTIPTION
COMPANY
Lotus Pharmaceutical is the largest pharmaceutical company in Taiwan by annual net sales and continues to grow rapidly with a strong pipeline and portfolio including high-barrier oncology, complex generics. Lotus is an integra...
...labeling materials with the Generics Law and other relevant laws.
c) Ensure regulatory support to GMP inspections if required
d)... ...relevant regulations (e.g. FDA
EMA).
Profici...
My client are seeking a highly skilled Regulatory Affairs Team Lead to join their dynamic team in India. The ideal candidate will have extensive experience in regulatory affairs, particularly in handling DCP submissions, and...
...Job duties of a Regulatory Affairs Specialist include:
Developing and implementing regulatory strategies for new and existing products
Preparing and submitting regulatory documentation to regulatory authoritie...
...closely working with Formulation, Regulatory, Intellectual Property (IP) and Business teams.
New product ideation to business, portfolio, and R& D team in development of the pipeline molecules
Propose clinical devel...
...regulatory requirements at GPC Medical.
Roles and Responsibilities
· Prepare and update technical documentations as per EU MDR and 510 (k) regulatory requirements as required.
· Prepare and update risk management...
...Medical Device Regulatory Affairs Job duties of a Regulatory Affairs Specialist include:
Developing and implementing regulatory strategies for new and existing products
Preparing and submitting regulatory documentation t...
