Dorizoe is a Specialty Contract Research and Services Organization delivering the best end-to-end solutions to global pharmaceutical industry catering niche segment comprising of parenterals, lyophilized, oncology injectables and other liquid and solid formulations.
Jr Executive - IRA (US & Europe Market) (0-2 Years) - Dorizoe Lifesciences Ltd
Job Description
Design, development and completion of regulatory dossiers for different pharmaceutical dosage forms, especially in injectables, inhalations and opthalamic and semisolid ointment/creams for regulated markets like USA & Europe, etc.
Compilation and quality review of CTD Module 1, Module 2, Module 3, Module 4 & 5 for bibliographic application.
Reviewing of Stability protocols, Specifications, STPs, Master Batch Documents (MBDs), PDRs, Checklists for TTD for adequacy and compliance.
To respond to queries received from various health authorities, clients and consultants.
Preparation and review of the administrative documents required for different regions (Module1) like SPC, PIL, mock-ups, risk management statements, Expert statements & application forms for submissions as per the respective regional requirements.
Product registration, Re-registration and amendment applications.
Effective liason with regulatory authorities for clarification on product development strategies, change in excipients, Innovator information and related queries, as and when required.
Maintenance of Dossiers and Regulatory documents.
Review of data adequacy for incorporating for regulatory submissions, like CMC (quality part), inserts, and other packaging materials (as per global labeling requirements) etc.
Monitoring and communicating new and changing regulations/updates and anticipate their impact on the current and proposed approvals.
Liases both at a peer level and a more senior level with related functional areas in the company to ensure quality and timely delivery of dossiers.
Handling multiple product projects at different stages of development.
Advice Company & client on regulatory pathway and strategy for products developed.
Interact with clients during conference calls to resolve regulatory related issues.
To submit Type IA, IAIN, IBForeseen, IBunforseen and Type II variation submission for Europe region.
Salary:
Not Disclosed by Recruiter
Industry:
Pharma / Biotech / Clinical Research
Farea:
Legal, Regulatory, Intellectual Property
Role Category:
Other
Role:
Trainee
Keyskills:
Regulated agenciesUS & Europe marketinternational & europeCTD compilationDossiers maintenanceReview of STPsReview of TTDReview of PDRQBD
Desired Candidate Profile
Education:
UG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
Please refer to the Job description above
Company Profile
Dorizoe Lifesciences Ltd
http://www.dorizoe.com/about-us.htm
Dorizoe is a Specialty Contract Research and Services Organization delivering the best end-to-end solutions to global pharmaceutical industry catering niche segment comprising of parenterals, lyophilized, oncology injectables and other liquid and solid formulations.
Omniscient Management & Technical Professionals form the foundation of the human resource complemented with state-of-the-art infrastructure with dedicated parenteral laboratory & containment facility.
We, at Dorizoe Lifesciences, believe in aiding the development of generic version of pharmaceutical products with a dual objective of catering to client"s needs and cost-containment in the pharmaceutical segment. We are determined to provide quality and time bound affordable product development services to the clients. Furthermore, the company desires to establish long-term amicable and symbiotic relationships, wherein strategic associations can result into mutual growth and benefits as well as upsides for the health care sector.
We, at Dorizoe Lifesciences don"t believe in simply meeting client"s need. We believe in surpassing their expectations and setting high standards.
View Contact Details
Contact Details
Recruiter Name:
Mr. Mitul Vyas
Email Address:
hr.corp@dorizoe.com
Telephone:
079-66197777
Reference Id:
DZ\IRA\01