Regulatory Manager-Reputed Healthcare Industry-Pune, Maharashtra, India- 15 LPA-Sonali-8657493492
21 hours ago
JOB DETAILS
Manage Pharmaceutical and biological documentation & Registration application for chemical active substances, biological medicinal products & data control activitiesSchedule as per Drugs and Cosmetics Act, India GMP and USFDA CGMP
Maintain Cell Therapy guidelines, USFDA guidelines, EMA
Animal Safety & efficacy studies with GLP certified laboratory/testing facility (Preclinical and non-clinical related activities)
Knowledgeable in CPMP-ICH or CPMP guidelines
Experience in Process Validation and Manufacturing Process Development
Experienced in Validation of Analytical Procedures and Stability Data
Adventitious Safety Evaluation and Process Validation Scheme for the Drug Product
Should have knowledge in validation of analytical methods and analytical methodology
Extensive knowledge of Pharmacology, Pharmacokinetics, Pharmacokinetics, Toxicokinetic, Toxicology, Genotoxicity, Carcinogenicity, Local Tolerance
Knowledge expert in Safety pharmacology studies for human pharmaceuticals
Knowledge expert in Single dose toxicity and repeated dose toxicity
Ensure Clinical trial and prepare Clinical Study Reports
Efficacy and Safety Studies
Should have Post-Marketing Experience
Statutory fulfillment
Present and conduct meetings with regulatory agencies, CROs, national & international authorities
Reporting weekly, monthly, quarterly, yearly meetings, updates, improvements
FUNCTIONAL AREA
Regulatory Affairs Manager, Regulatory Manager, Quality Assurance, QA, QA Head, Head Quality, Regulatory Affairs Executive, Regulatory Affairs, Quality Assurance Manager, CMC, Stem Cells Theraphy, Cells Therapy, Biopharma, Biotechnology, Jobs for Regulatory Manager in Healthcare Industry, Jobs for Regulatory Manager in Pune, Healthcare placement agencies in Pune, Healthcare Recruitment agencies in Pune, Healthcare placement agencies in Maharashtra, Healthcare Recruitment agencies in Maharashtra, Healthcare placement agencies in India, Healthcare Recruitment agencies in India, placement consultancy in Pune, best placement consultancy in Pune, top placement consultancy in Pune, placement consultancy in India, best placement consultancy in India, top placement consultancy in India.
Apply Now
-
Pune, Maharashtra, India Seven Consultancy Full timeJOB DETAILSResponsible for operating the F & B outlet assigned to him/ herTo recommend food and beverage service standards & implementFollow standard operating procedureDegree/Diploma holder of HMGuest interaction, menu planning FUNCTIONAL AREA F&B Associate, Senior Steward, Sr.Waiter, Stewardess, Waiteress, Hostess, Food & Beverage Management, Jobs in...
-
Pune, Maharashtra, India Seven Consultancy Full timeJOB DETAILS Managing PPC campaigns, monitoring reports, and ROIWriting SEO copy for the websiteMeasuring the performance of campaigns through web analytics tools (Google Analytics, WebTrends, etc.)Managing and updating social media platformsKeeping up-to-date with trends in social mediaCreating innovative contentOverseeing the company's email marketing...
-
Pune, Maharashtra, India Seven Consultancy Full timeJOB DETAILS Be familiar with sanitation regulationsSetting up of the kitchen with cooking utensils, equipment, cutlery etcCook food in a timely mannerAssign tasks to kitchen staffsEnsure the safety and hygiene of the kitchenSupervise cooks and offer assistance whenever neededExperiment with new recipesEnsure compliance with the health and safety...
-
Pune, Maharashtra, India Seven Consultancy Full timeJOB DETAILS Provide inspired leadership for the organization.Make important policy, planning, and strategy decisions.Develop, implement, and review operational policies and procedures.Assist HR with recruiting when necessary.Help promote a company culture that encourages top performance and high morale.Oversee budgeting, reporting, planning, and...
-
Pune, Maharashtra, India Seven Consultancy Full timeJOB DETAILS Collecting, interpreting and reviewing financial informationPredicting future financial trendsReporting to management and stakeholders, and providing advice how the company and future business decisions might be impactedProducing financial reports related to budgets, account payables, account receivables, expenses etc.Developing long-term...
-
Pune, Maharashtra, India Seven Consultancy Full timeJOB DETAILS Develop and implement HR strategies and initiatives aligned with the overall business strategyBridge management and employee relations by addressing demands, grievances or other issuesManage the recruitment and selection processSupport current and future business needs through the development, engagement, motivation and preservation of human...
-
Pune, Maharashtra, India Seven Consultancy Full timeJOB DETAILS 1. Providing legal advice and support on wide range of legal activities relating to Power Sector.2. Proficient Knowledge of all Acts and legislative policies relating to Power sector.3. To pro-actively create and maintain awareness of statutory guidelines for (compliance perspective on relevant laws and regulations.4. Advising on renewable...
-
Pune, Maharashtra, India Seven Consultancy Full timeJOB DETAILS 1) Find VendorsVendor managers research vendors to find the best products and prices available within a given market.2) Establish StandardsVendor managers establish standards and guidelines for vendors, monitoring vendors to ensure these policies are being followed.3) Hire New VendorsVendor managers conduct interviews and meetings with new...
-
Pune, Maharashtra, India Seven Consultancy Full timeJOB DETAILS Organizing materials and ensuring sites are safe and clean.Preparing cost estimates and ensuring appropriate materials and tools are available.Providing technical advice and suggestions for improvement on particular projects.Diagnosing and troubleshooting equipment as required.Negotiating with suppliers and vendors to ensure the best...
-
Pune, Maharashtra, India Seven Consultancy Full timeJOB DETAILS 1) Monitoring of manufacturing activity & General Area Formats & BMR -Online.2) Crosschecking of Issued Primary packaging materials.3) SOP Training, BMR preparation.4) Monitoring of on line particle counter.5) Manufacturing tanks vent Filters & silicon tubing replacements6) BMR reconciliation and completion.7) Shift schedule preparation.8)...
