Candidate with 3-5 year of experience in regulatory filing for ROW and Semi- regulated marked for Injectable Formulation.
Advantage if handled eCTD submission and exposure of Regulated Market and other Dosage form.
Should be capable of handling...
Position: Head – Content Research & Compliance Consulting
Qualification: Llb / Llm
Regulatory Compliances, Research, Consulting In Compliance Management, Legal Counsel And Compliance Officer, Program Management, Very Good Spoken &...
Key Skills : skills: regulatory compliances,research,consulting in compliance management,legal counsel and compliance officer,program management,very good...
RS1,25,000 To 2,50,000South Delhi, West Delhi, Delhi
- Preparation of dossier in CTD/ACTD format, Analytical skills for evaluating technical documents.
- Communicating with the different department of Manufacturing Unit (QA, QC,Production etc)
- Handling of NOD / resolving query
- Preparation and compilation of Module 2, 3, 4 and 5 for the regulated markets (Europe/Australia/Canada) in CTD/eCTD format.
- Handling queries on Quality, Clinical, Non-clinical and Bio-equivalence parts received from the different regulatory auth...
Submission of Module 2-3 Variation Filing, Responding Regulatory Queries, Literature Clinical Data
*preparation & Registration of Dossiers as per Country Guidelines and Checklist
*review of Product Development Report, Specifications
JD of Regulatory Affairs:-
1. Level- GM
2. Age Group : 40-45 Years
3. Qualification-Engineering with MBA (finance)/CA with LLB
4. Experience-At least ten years in working Power Sector preferably in Commercial and Regulatory matters. Knowledge ...
Key Skills : general manager,senior general manager,regulatory officer
Leading Conglomerate venturing into Oil & Gas is actively looking for a DGM / GM - Regulatory role in Mumbai with .
1. Responsible for obtaining, preparing and analyzing information necessary for filing regulatory documents to ensure complianc...
Key Skills : general manager,regulatory management,regulatory officer,gas turbine,cost estimation,regulatory...
To make calls, emails to higher executives (Like Purchase Head, VP, Directors. etc.)
To be able to achieve monthly financial targets
To meet with the clients, presenting the business proposal
To be able to handle the customer queries
To be able t...
Key Skills : business development executive,purchase head,procurement specialist,purchase officer,purchase...
Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements – all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs departments of life-science co...
Key Skills : drug regulatory affair,regulatory affair,legal officer
1) Procurement of Raw Material / Packing Material / Machinery /Stationers etc.
2) To monitor daily stock level closely and to maintain co-ordination with plant and production persons on daily basis.
3) To float inquiries, make comparative sheet of ...
- The primary responsibility of the Senior Internal Auditor is internal audit, internal controls, risk management, regulatory compliance and reporting functions.
- supervises execution of internal audit plan by leading or conducti...
Legal advisor in relation to specified Litigation & Non Litigation matters and provide legal, commercial and strategic advice in consultation with Counsels on all areas of law.
Manage the companys disputes and litigation & Non litigation (in...
Coordinate with land owners, Business Development/ Land Purchase and Liaison Departments to obtain necessary property details, documents and information.
Draft legal documents (Preliminary little flow and title opinion, MOU, Joint Development Agreem...
Strong Ethics and Integrity.
knowledge in Ce Marking and Fda
iso 13485, Documentation
strong Technical/functional Knowledge.
4 -8 Years of Experience in Medical Devices
engineering / Be / Biomedical/electronics
ecg, Patient Monitors, Multipara ...