Search Results: 15 vacancies
...firepower.
Welcome to the relentless pursuit of better.
Inviting applications for the role of Lead Consultant Regulatory Affairs, CMC for UAE markets.
In this role Candidate should have experience in regulatory affairs while essential exposure to the lifecycle...
The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to...
...Lead Consultant Regulatory Affairs, CMC for UAE markets - LIF015124
With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent...
...location exceed benchmarks
# Coach MPs and APs on management/sales skills and career growth
# Contact APs who are falling short of CMC criteria to re-activate them
# Works closely with the training team to organize regulatory and skill development programs
# Propagates...
...activities.
Preferred candidate profile
Team Handling Experience is preferred.
Experience in US submissions.
Knowledge of CMC Documentation required for Submissions.
Knowledge & Experience of Pharma ready Software.
Role: Legal & Regulatory - Other...
...• Responsible for P to P (Purchase to Payment), understanding of payment terms for Exp-LC Payment terms
• Responsible for AMC, ARC & CMC
• Ensuring safe operations of stores activities
• Inventory control & Store Management - RM & SPARES - RM & ENGG Spares
NATURE...
Rs 5 - 6.5 lakhs p.a.
...perform closure of contract in system.
13 QSD validation of non-tech service bills (e.g. manpower supply,
AMC for Admin/ IT jobs, CMC related transport etc.).
14 Coordinate and facilitate ICS transactions for inter-site
movement of material ensuring regulatory compliances...
...product plan development and implementation , regulatory strategy , risk management , chemistry manufacturing control (CMC).
Ensures timely approval of new drugs , biologics or medical devices and continued approval of marketed products ....
...1) Configurations using CMC - Organizations, Catalogs, Spaces, Authentication, Plans etc.
2) Managing RBAC and privileges.
3) User Management for development activities
4) Applying fixpacks upgrade
5) Troubleshooting application connectivity
6) Creating configuring...
...professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!
Job Purpose:
Provide and ensure timely preparation of high-quality CMC regulatory documentation and support in line with global regulatory submission plans and strategies.
Major Accountabilities
Life...
...maintenance activities for assigned products, including but not limited to the following:
• Variations (Administrative, Labeling, CMC, Safety, dossier harmonization): Submission strategy / provide RA Assessment through change management system / CMC Assessment / Timelines...
...# Responsible to provide CMC regulatory strategy as the CMC regulatory lead for drug substance and drug product during different clinical phases.
# Responsible for dossier/CMC document submissions timely by ensuring the complete contents. Provide support to maintain regulatory...
...& Compliance
Study of As Is process & defining To be Solution path for the identified pain Areas
Preparation of Process (PMC/CMC) note to capture processes along with responsible team
Customer Vendor Project/Product stakeholder Management and Implementation...
...Regulatory lead will support in providing CMC strategy for drug substance and drug product during different clinical phases.
Responsible for product registration, approval and regulatory compliance throughout product life cycle.
The individual will be involved in CMC...
...business development /technical sales in specialty chemicals preferably in Pulp/Paper, Textile, water treatment, viscose .
Experience in CMC Chemistry; Alkoxylation, Chelates chemistry and application among others
Great if you have:
Distribution management experience...
