...regulatory authorities) on defined matters.
·
Face external audits / inspection, coordinate and communicate with external auditors / inspectors for compliance.
Qualifications
Expertise in regulatory compliance ...
Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmace...
...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...
Lead the transfer of API production processes from development to pilot plant scale, ensuring seamless execution and adherence to project timelines.
Collaborate with cross-functional teams including process development, manufacturing, quality assuran...
...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...
...skill
Should adhere to the SOPs and policies all time
Should have experience of Audit handling
Should adhere to data integrity policy all time
Should complete training as the schedule
Should have minimum awareness on reg...
.... All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA...
Experience: 10 years to 15 years Location: Aurangabad
Client: Pharma client(API)
Fraction IT Solutions Pvt Ltd is hiring Regulatory Affairs (DMF) experts for its Pharma client which is an established Capability Development center at Aurangab...
