Gm Regulatory Affairs

Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...

**Job highlights** - Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science. Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm. - Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation **Job description** This is a...

Job Summary The Regulatory Affairs Specialist is responsible for ensuring compliance with all applicable regulations governing the development, manufacturing, and distribution of the company's products. This role involves collaborating with internal teams and regulatory agencies to facilitate product registrations, approvals, and adherence to quality...

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice, is searching for an Executive - Regulatory Affairs (PLMDS) to join one of our clients. **Main Job Tasks and Responsibilities**: - Complete...

General Accountability Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files. **Responsibilities**: 1. Write, analyze, and edit...

Job Responsibilities for General Manager (GM) Operations in Facility Management at TOT Hygiene Private Limited: **1. Client Management**: - Manage client relationships and ensure high levels of customer satisfaction. - Understand client requirements and provide effective solutions. - Address any issues or concerns raised by clients promptly. **2. Site...

Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post - approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists -CMC (GRSs-CMC) under the guidance of the team lead. The activities...

Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post - approval regulatory submission activities for Brands in collaboration with Global Regulatory Strategists -CMC (GRSs-CMC) under the guidance of the team lead. The activities...

Committed to quality and excellence in compliance and conformance. - With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned. - Accountable for maintaining the RA status in corporate change and dossier management system for the allocated Regions / Markets - Contributes independently and manages...

**Job Description**: Committed to quality and excellence in compliance and conformance. - With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned. - Accountable for maintaining the RA status in corporate change and dossier management system for the allocated Regions / Markets - Contributes...

Job Description:Oversee the whole accounting operations which includes accounts receivable, inventory process, accounts payable process, finance and treasury matters, tax and government regulatory requirements; Identify and implement work flow improvements to strengthen internal controls and improve work efficiency; Ensure timely reporting and review of...

Job Description:Oversee the whole accounting operations which includes accounts receivable, inventory process, accounts payable process, finance and treasury matters, tax and government regulatory requirements; Identify and implement work flow improvements to strengthen internal controls and improve work efficiency; Ensure timely reporting and review of...

**Roles & Responsibilities** Managing the budgeted targets for the respective states to meet the Sales turn over and Sales collection to ensure the desired business growth with timely forecasts, planning, indenting, stock procurement, invoicing and managing the receivables, Inventory, Collections and Extension work (RICE), including the product promotion...

**Industry** Pharmaceuticals, Cosmetics, Medical Devices, Food Supplement, Labeling and Scientific Communications **Position** Full Time, Permanent **Division** Pubrica Brand **Reports to**: Pubrica Business Head **About Company** Guires Group is a renowned global provider of services in advanced Contract Research, Data Science, Development, Pilot...

Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

**Regulatory Middle Office-** Role Description The role will have responsibility for: - Working with the Regulatory Middle Office function globally to identify, escalate and potentially remediate issues and reporting defects - Assist in the generation of periodic and ad-hoc Regulatory Reporting management information metrics - Delivering Global Control...

Responsibility: - Functions as Support to Product Lead for Life Cycle Management (LCM), - working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. - Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections for post approval submission. - Responsible for...

Manages day-to-day regulatory activities associated with assigned Renewals within agreed upon timelines under the guidance of Team Lead / designee. Has fundamental knowledge of the principles and concepts of process been followed, the activities which includes but not limited to: - Authors and/or compiles CMC contributions for renewals, i.e. Module 1,...

Key ResponsibilitiesDevelop and implement strategic business plans to achieve sales targets and maximize revenue growth for the Rx vertical.Analyze market trends, competitive landscape, and customer needs to identify opportunities for product differentiation and market expansion.Build and maintain strong relationships with key customers, including healthcare...