Search Results: 10 vacancies
...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...
...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...
...activities
Skills and Requirements
Experience in US submission
Experience in US submission
Knowledge of the review of CMC documentation required for submission
Working capabilities preferably on PharmaReady software
Understanding labelling related guidance...
...Skills & Experience:
~ Significant experience of working in an equivalent role (Formulation development / QA / Production / Regulatory CMC) within a pharmaceutical company handling the following:
Process validation
Analytical validation
Microbiological / Sterile...
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...
...services, and expertise in data, technology, and AI.
Inviting applications for the role of Lead Consultant Regulatory Affairs, CMC and labelling for Dubai market
In this role Candidate should have experience in regulatory affairs while essential exposure to local...
...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...
...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...
...& 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...
