Sakshi Dagar
Assistant Manager Regulatory Affairs @ MED-EL
About
Gathering, evaluating, organising, managing and collating information in a variety of formats. Submitting information and responding to queries from regulatory bodies. Experience in both drugs as well as medical devices. Willing to learn a lot more.
India
Delhi
Medical Device
Microsoft Office, Dossier Preparation, Pharmacy, Regulated Industry, Editing, Regulatory Approvals, Product Registration, Medical Devices, Running, Medical Device Regulation (MDR), Active Listening, Regulatory Negotiations, Teamwork, Training, Regulations, Regulatory Requirements, Import Compliance, Renewals, Easily Adaptable, Internal and External Communications
Experience
Assistant Manager Regulatory Affairs
MED-EL
India
Assosiate regulatory affairs
MED-EL
New Delhi
Junior Associate Regulatory Affairs
MED-EL
India
Handling regulatory submissions & queries as per EU MDR (New approvals / PAC). Preparation of India specific labels and reviewing other Import requirements for Medical Devices as per Medical Device Rules 2017. Reviewing and managing database circulation among India team and the Head Quarters (Austria). Developing a strong understanding of industry regulations to ensure compliance within daily operations. Coordinating well with the team and consultants to avoid any non-compliance in documents. Ensuring timely completion of projects through diligent monitoring of deadlines (Auditing stores department). Checking for the updates regularly on the CDSCO portal.
Officer
MEDICAMEN BIOTECH LIMITED
Delhi, India
Have appropriate knowledge about the documents, analysis and dossiers as well.
Trainee
PSYCHOTROPICS INDIA LIMITED
Assisted in the development of documents such as checklists and labels.
Education
Uttarakhand Technical University
Pharmacy
Overall percentage = 80%
Uttarakhand Technical University
Biopharmaceutics
Overall CGPA = 8.78
Sakshi Dagar's Contact Information
Phone
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