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.
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.
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...
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...
Review and Submission of Drug Master File (DMFs) for US, EU & Japan, Submission of Certificate of Suitability (CEPs) dossier for EDQM, DMFs for Health Canada and Updates.
Handling of deficiencies raised by FDA during the course of reviewing of the...
Central Drugs Standard Control Organisation (CDSCO) FDA Bhawan, New Delhi
RS Up To 3,25,000 Hyderabad, Sector 18 Chandigarh, Mohali ( Chandigarh ), South Delhi, East Delhi, Central Delhi, 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
Job Description :-
Candidate should have experience in Pharma Industry Only
Ensure that all the functional / operational and safety procedures are adhered during the routine working at R&D to ensure compliance
Performing Literature a...
- 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...
Should able to handle all company legal matter\'s.
2. Should consult and assist in legal matter\'s.
3. Liable for drafting the legal documentations as per Company requirements.
Salary: 1,00,000 - 1,25,000 P.A
Industry:Construction / Engineering /...
• 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...
• 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
Origin Consultants Pvt Ltd has been retained by One Of The Largest Conglomerates In Korea With Assets US$83 Billion, Sales US$24 Billion to identify a General Manager - Corporate Affairs and Strategic Alliances to be based at Mumbai
Key Skills : general manager,senior general manager,deputy general manager
RS 3,00,000 To 4,25,000 Baddi, Mohali ( Chandigarh )
•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...
1. Financial statement analysis and commentary on financial performance of the counterparty. 2. Prepare financial spread, including forecasting and/or stress, test, to generate financial ratios and internal credit rating. Compasing both Industry / Bu...
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
-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...
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...
- Reviewing Doc From Adl, R&D, Quality & Prod.
- Life Cycle Management Through Amendments / Annual Reports.
- Managing Databases And Up-Keeping Of Recording Systems
- Preparation And Reviewing Of Regulatory Dmf.
- Response To Customer Dmf...
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...
preparing & submission of Dossiers for Product registration.
2. Ensure accuracy, completeness and quality of regulatory submissions.
3. Ensure that all product artwork is updated when necessary and submitted in correct format and that subsequ...
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
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
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...
Work Under Fair Knowledge of Company Law & all Work Related with Registrar of Companies
drafting & Vetting of Various Agreements such as Leave & License Agreements, Non-disclosure Agreements, Distributorship Agreements Etc. Internet & Roc Searche...
Synapse Clinical Research Foundation (SCRF), Delhi NCR
Synapse Clinical Research Foundation (SCRF), a non-profit organization promoting transparent, accountable and ethical conduct of clinical trials in India for patient's welfare since 2005. SCRF i...
Key Skills : clinical associate,clinical assistant,senior clinical research associate
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.
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...
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...
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
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...
Hiring Life Science Graduates with experience and TRAINED in CRA/CRO/CDM/PV/Regulatory
• Any Life Science graduate with an exposure to Clinical research domain
• Having a prior exposure/experience in Clinical document management/ Clinical d...
Key Skills : clinical data coordinator,clinical research associate,clinical research analyst,clinical data management,pharmacovigilance,medical coding,regulatory,...
RS 3,00,000 To 9,00,000 Ahmedabad, Surat, Vadodara
i. Thorough understanding of ISO 13485, ISO 22593, MDD regulations is mandatory for applying to this job.
ii. Responsible for coordination and preparation of regulatory submissions DCGI and CE submissions
iii. Should have thorough understan...
Post Offered: Law Officer
Location: Samrala, Distt. Ludhiana,Punjab
o Candidates should have Bachelor\'s degree in Law (LLB or equivalent – full time degree) from recognized Indian Universities. The degree should also enjoy...
Key Skills : law officer,legal services,legal consultant,legal advisor
RS 2,00,000 To 7,00,000 Bhilai Nagar, Raipur, Mysore, Nagpur, Nashik
THIS IS A CONSULTANCY FOR CHARGEBAL SERVICE AND BACKDOOR ENTRY
Qualifications Required: - ITI/DIPLOMA/B.TECH/CS/IT/MBA ALL ENGG BRANCH
Req: site engg
POST WITH SALARY
* ITI = 7000 - 11200/-
* DIPLOMA= 11500 - 14500/-
* B.TECH = 15500 - 22500/-...
Key Skills : site engineer,engin,maintenance engineer,site engineering,civil site engineering
Drafting various contracts as per the requirement of each respective business vertical.
Reviewing and providing comments and suggesting changes in order to protect the interest of the company on contracts forwarded for inputs.
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
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...
RS 20,00,000 To 25,00,000 Central Delhi, Mumbai, Delhi
1. Financial statement analysis and commentary on financial performance of the counterparty.
2. Prepare financial spread, including forecasting and/or stress, test, to generate financial ratios and internal credit r...
RS 3,00,000 To 5,00,000 Baddi, Mohali ( Chandigarh )
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 Regulatory Affai...
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...