Cmc

**Trainee CMC** The Trainee - Regulatory Affairs will be a part of the GRACS team which supports regional CMC strategy, preparation of CMC documentation. Under the direction of the area supervisor, responsible for the planning, preparation, and release of regulatory submissions (IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, etc.) and...

Deliver the CMC activities by achieving the agreed Quality Cost Delivery (QCD)Build and optimize the global CMC development plan with the CMC team members, according to the project objectives.  Manage all activities and action plans in line with QCD commitment. Ensure all activities follow standard processes (Project Management and Standard Operating...

Job Responsibilities:1. Biosimilar Regulated market submissions - US / EU market submission. Preferred US FDA .Alternatively candidates having exp in Small molecules and injectables for US.2. Should Have dossier authoring for CMC for EU market.3. Should have authoring of pre approval dossiers and query responses for US and EU.4. Biosimilar Product...

**Scientist Regulatory Affairs CMC** This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance’s and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for...

Required Skills and Experience :Master or engineer or PhD in pharmacy or chemistry10-15 years in similar position as analytical expert in pharmaceutical developmentGood understanding of CMC technical aspects Expert knowledge in the pharmaceutical development activities (formulation, process, analytical Knowledge of good manufacturing practices and marketing...

Designation Asst Manager Global Regulatory Affairs CMC On a Contract Department Global Regulatory Affairs CMC Contract Duration 12 Months will be working on Talisman payroll Not renewable Location MIDC Andheri East Mumbai Working Day Monday To Friday Time 9 A M To 6 P M Primary Job Function 1 Product registrations Submissions -Assists in product...

Job Description The Position Although one or more potential candidates for this position have been identified, we will consider applications from any interested applicants." The Senior Scientist is responsible for implementing Regulatory Chemistry, Although one or more potential candidates for this position have been identified via internal succession...

**Process Documentation Role with leading Bank**: - From 3 to 8 year(s) of experience - ₹ Not Disclosed by Recruiter - Mumbaior **Roles and Responsibilities** **Process Documentation Role with leading Bank** Roles and Responsibilities: EGRC Process Management covering Process Review, Triangulation & Rationalization (For all units across the Bank): -...

**POSITION PURPOSE**: The Servicing Quality Control associate will be responsible for testing and QC of loans for the servicing department. Will assist in training and development of the offshore team as well as work directly with the client to strengthen business relationships and continuity. **Responsibilities**: - *Perform servicing testing reviews on...

We are seeking three Global Regulatory Affairs Specialists to provide critical subject matter expertise and backfill internal SMEs during a major regulatory transformation initiative. These roles will ensure continuity of day-to-day regulatory operations - particularly across CMC, labelling, and lifecycle management activities. This opportunity can be...