Sr. Exe. Regulatory affairs (CMC)
About CHANDRESH BODH:
I am Ms. Chandresh Bodh, with over 7.5 years experience in RA CMC, with a Master’s degree in pharmacy from Mahamaya Technical University, Noida, India.
Currently working as a “Sr. Officer Regulatory Affairs in Florencia Healthcare pvt. Ltd.
v Preparation, Compilation and Review of high-quality CMC documents for regulatory submission of new registrations, renewal projects and post approval changes.
v Knowledge of EU procedures, i.e., CP, NP, MRP, DCP, product lifecycle management and Market Authorization (MA) compliance.
v Follow-up with clients and regulatory authorities to obtain timely product approval.
v Preparation of Quality Overall Summaries (QOS) for drug product and drug substance.
v Solutioning approach, ability to build new capabilities, take ownership and deliver projects per client requirements.
v Response for deficiency letters from various regulatory authorities.
v Knowledge of review and assessment of CMC supporting technical document for like Pharmaceutical Development Report (PDR), Analytical Validation Report (AMV), Process Validation Report (PVR), MSDS, DMF, Specification, Testing procedures & Certificate of analysis (API, Excipients, Finish product & Packing material), stability documents and Summary of Product Characteristics.
v Prepare & review content for Artwork (Printed carton, Printed alu. Foil, Label and Inserts etc.)
v Coordination with the plant for technical requirements for the compilation of dossiers.
v Research oriented with experience in literature review and technical writing.
v Formulation discussion for applying Permission, COPP, FSC Manufacturing License & Product permission with QA, QC, Production & Drug department.
v Keeping track of registration status and supplying additional documents required by them from time to time.
v Knowledge of current regulatory guidelines.
I have done master in pharmacy in pharmaceutics from mahamaya technical university, Gautam buddh nagar, India.
Professionals who compete with CHANDRESH
Professionals in the same Healthcare sector as CHANDRESH BODH
Professionals from different sectors near Noida, Gautam Buddha Nagar
Other users who are called CHANDRESH
Jobs near Noida, Gautam Buddha Nagar
Virtuous Advisors & Resources Private Ltd (Virtuous Resources) Delhi, India Full time
Job Description: · Should have strong relationship/network base across Large, Mid-Corporates or SME across the region. · Ability to write Credit Notes · Should have the ability to generate leads throu ...
Employ Berry Gurgaon, India
Dashboard · Positions · BDM Enterprise Solution · BDM Enterprise Solution · ActiveBDM · BDM Enterprise Solution · at Hi-Tech e Soft · Posted On :04-Aug-2023 · Location: · Gurgaon · Salary: · INR 1,400 ...
NRV DesignX Delhi, India
We are looking for a · Project Coordinator to take care of Project execution activities with Client and looking to shift from Manufacturing domain to IT domain. · Key Competencies · .Diploma/Degree i ...