Responsible for effectively manage the Corporate compliances along with all the secretarial activities. Work closely with the legal & regulatory team on regulatory, policy & other legal issues.
Implementation of well-defined standardized
Key Skills : company secretary,company secretary & legal,cs,company secretarial,pune
The Work Activities Will Include Providing Remote Cmc Regulatory Support in the Preparation of Various Submission Dossiers in Collaboration with the Client Team for Investigational and Marketed Pharmaceutical Products.
Regulatory - Executive
Qualification: B.Pharma / M.Pharma.
Experience : 3-4 years in Pharma / Chemical Industry.
Location of posting: Kolkata
Key duties of the job :
Studying scientific and legal documents.
Assist with the case processing, submission, tracking and maintenance of individual case safety report and medical device report documents involving approved products.
Assist with the processing, submission, tracking and maintenance of safety report...
Roles and Responsibilities
Advanced Quality Engineer shall develop the overall quality approach for new products and line extensions within the new product development and specials process. This includes quality engineering oversight, quality syst...
•Strong With Regulatory Documentation
•Mfr/Sop/Amv(Analytical Method Varidation),Actd/Ctd, Dossier Preparation
•Having A Sound Knowledge Of Bmr Preparation And Filing, Fr&D Documentation, Pv Etc
• Will Be Responsible For Handling Reg...
please Refer to the Jd:
duties and Responsibilities
-analyze Diagnostic Tests to Measure a Patient\'s Heart Rate, Monitor Cardiac Rhythm and Help Physicians Find Irregularities in the Heart and Blood Vessels.
We are looking for a profile with atleast Fifteen Years in Working Experience with Power Sector Preferably in Commercial and Regulatory Matters. Knowledge of Regulations and Practical Experience in Working with Regulators. Knowledge of Accounts and T...
A. 10+ Years Experience in Development of New Medical Devices Products Involving Mechanical, Electrical Hardware, Firmware and Software
b. Strong Program Management Skills Interfacing with Multiple Stakeholders in R&d, Quality and Marketing Teams\...
Key Skills : medical devices product manager,medical devices,regulatory compliance,regulatory affairs
RS 1,50,000 To 3,75,000 Hyderabad, Hyderabad / Secunderabad
We are looking for Life-sciences, Pharmacy, Dental & Medical graduates & postgraduate fresher's for Clinical Research, Clinical Data Management, Pharmacovigilance, SAS, CDISC SDTM, Medical Coding, Medical Billing, & Regulatory Affairs pos...
- Drafting various deeds and Documents and Contracts etc.
- Tender documents, Development Agreement,Lease Deed,Leave and License Agreement
- Handling Property, intellectual property rights, Registrations,Customer Queries
• New Business development for Finished Formulations.
• Market research & competitor analysis for business development.
• Marketing of existing products and services & evaluating market potential for new products.
• To look after the regis...
Key Skills : sales executive,marketing executive,business development executive,bpo executive
Searching in different patent databases and analyzing patent publications.
• Perform various other types of patent analyses, such as, claims mapping, portfolio analysis, patent
categorization, patent valuation etc.
• (Assessment) in el...
Key Skills : candidate should be having post graduate diploma in patent law/ ipr.,candidate should be focussed,a good learner,and good written,candidate should...
RS 22,50,000 To 50,00,000 & above China, Weihai,Shandong
1:Handling of Tablets, Capsules, Oral Liquids and Oral Suspensions.Handling of Injectable Liquid and Lyophilized Formulations.Knowledge about the handling of Cytotoxic materials.Knowledge about the safety aspects.Knowledge about GLP and GMP.Knowledge...
Key Skills : drug analysis,development,r&d,lab,formulation,regulatory affairs
Proofreading of Manuscripts
Handling various types of articles for the Graphy Publication Journals
Copy editing for quality content in the articles and plagiarism check.
Making sure the language is apt for the particular research papers.
Key Skills : excellent communication skills with fundamental computer knowladge,assistant managing editor,content editor,content developer,content writer
Can review protocol and report of qualification and validation activities.Review of SOP.Deliver Training.To perform invstigation of failure.Review of Batch records.Review of QMS records. Review of IPQA activities on shop floor.Conduct self inspection...
Archivist Core responsibilities include
Conduct data archival awareness and training sessions
Has good understanding of Data retention requirement on business needs and financial, legal and regulatory requirements
Coordination with Business Stake...
Key Skills : records management data management cost saving archival ass,records management,data management,archivist,legal advisor,consultant,legal...
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...
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 ...
• He/She will look after export marketing, regulatory affairs, costing, negotiation, executions, logistics and export documentations.
• Should have good communication skill with English fluency.
• Should have minimum of 3 years of experie...
Coordination with departments for dossier planning, preparation & approval as per Country Guidelines, Query Handling, Art Work Review, Registration process of products in new countries, Impartation of trainings ICH, CTD & ACTD Guidelines etc.
Key Skills : ctd,actd,ich,dossier,art work review,registration of products,pharmacist,pharmacy manager,pharmacy incharge,pharma associate
- 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...
1. the Candidate Should Be B.pharma
2. Working Experience in Who Certified Manufacturing Unit is Must.
3. the Candidate Must have Regulatory Work Experience of Preparing
dossiers for Different Countries, Knowledge and Experience of D...
Review, draft, and implement legal regulatory and compliance programs; provide necessary training relative to rollout of new initiatives
Select, test, and implement software programs to facilitate compliance requirements including procedure drafting...
Review of Legal Contracts and Documents Viz. : Sale and Service Agreements, Partnership Agreements, Lease and License Agreements, Employment Contracts, Due Diligence, Non Disclosure Agreements, Etc.
- Regular Correspondence with the Parent Company a...
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
Given in an opportunity to work closely within a Pharmaceutical & Biotechnology consulting company, you will be able to catalyze the organizational growth by providing regulatory in-sights for specific products for Indian market.
5 to 20 years experience in Legal/ Liaisoning
- Should have hands on experience in coordinating with all govt.
- Legal / Govt. letter drafting skill is must.
- Typing knowledge (Hindi & English)
- Ensuring statutory c...
Overall responsibilities of Quality Control Laboratory including Instrumental Lab, Chemical Lab., and Microbiology.
To ensure the compliance of current Good Laboratory Practices and Standard Operating Procedures in the QC Laborator...
We are a progressive Pharmaceutical Company. We have a modern office in Andheri Mumbai. We take each year Fresh Pharmacy Graduates, Post Graduates OR MSc candidates. They are exposed to various functionalities such as Business Development, Regulatory...
Description: Enroll For Full Time/Part Time Clinical Research Course In ProRelix & Grab Your Chance to Work In Pharma/CROs/SMOs/IT/Hospitals.
Exp: 0-3 year
Annual Salary: 1.2-2.4 lakh/annum
Courses Full Time & Part Time: Clinical Research Sy...
Key Skills : clinical research executive,research associate
Preparation , review and timely submission of DMF (CTD / ACTD formats) as per plan.
2. Review of Technical documents received from various Site
3. Coordinating with R & D , QA , Production , ADL and Purchase for collection of Technical data f...
Central Drugs Standard Control Organisation (CDSCO) FDA Bhawan, New Delhi
RS Up To 3,25,000 Hyderabad, Sector 18 Chandigarh, South Delhi, East Delhi, Central Delhi, Mohali, Roorkee, Delhi
Import & Registration Division:
•Scrutinize & examine the Drug Master Files (DMF), Plant Master File (PMF), GMP certificates & COPP etc. from overseas manufacturing units pertaining to Registration & Import License of Drugs, under Form 41, a...
Key Skills : drug regulatory affair,clinical research,epidemilogist,pharmacovigilance,technical documents
-Handling query receive from various Security agency in MP & CG Circle
-Monthly maintaining reports.
-Putting the Number of interception as per request received from security agency.
-Submitting the data to security agencies in...
RS 2,00,000 To 3,50,000 Dehradun, Haridwar, Roorkee
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
RS 1,25,000 To 2,50,000 South 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
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...
Financial Planning and Analysis
- Prepare and maintain regular financial planning reports; Monthly profit and loss forecast by division (vs. budget).
- Complete analysis of financial results; Develop recommendations (strategic and tactical).
RS 3,00,000 To 8,00,000 Ahmedabad, Surat, Vadodara
Perform all quality control analytical instruments. Management System Implementation like Quality Management System, EMS & OHSAS, Direct & Coordinate the company's Quality Assurance Program, procedures and regulatory affairs, etc.etc.
Key Skills : quality assurance assistant manager,quality control assistant manager
Experience Educational Qualification Roles & Responsibilities Support Product Owner In Assembly Of Process/Product Regulatory Submission And Assist In Follow Up Questions.
Understanding Of International Regulatory Requirements For Medi...
Key Skills : medical devices,medical devices operator,medical devices engineering