Regulatory Writing and Submission Scientist

Why Patients Need You Seeking a Regulatory writing submission scientist (RWSS) who will liase with Drug Safety Research & Development (DSRD) Regulatory Strategy Leads and Medicine Design/PDM colleagues to prepare and support the expert nonclinical sections (pharmacology/ADME/toxicology) of regulatory dossiers and oversee the integration of all nonclinical...

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...

Our people work differently depending on their jobs and needs. From hybrid working to flexible hours, we have plenty of options that help our people to thrive. This role is based in India and as such all normal working days must be carried out in India. Join us as a Regulatory Control Associate - This is a great opportunity to join our business and play a...

ROLE SUMMARY ROLE RESPONSIBILITIES - Auditing (verifying) of data and information against source documents and data systems for completeness and accuracy. Perform data verification of Biologics License Applications, Investigational New Drug Applications and other regulatory documents in compliance with Pfizer internal Standard Operating Procedures. Perform...

**Regulatory Affairs** **This is us**: Ovesco Endoscopy is a research-based medical device company specializing in flexible endoscopy. We develop, produce, and sell highly innovative instruments and systems for the treatment of gastrointestinal diseases. We offer comprehensive procedures and accompany our customers all the way from training to...

The Strategy & Enterprise Analytics team under Connected Vehicle & Enterprise Analytics organization in GDI&A leverages advanced analytics and domain expertise to deliver data analytics models, tools, and services to improve the EV customers’ charging experience, support Ford strategic energy services, meet or exceed regulatory compliance via connected...

Reporting to: Assistant Manager – Regulatory Affairs Division: Ortho Implants Location: Chennai No. of Positions: 1 Education: B.E/ B. Tech in Biomedical Engineering / M. Pharm Regulatory Affairs Experience: 2 - 4 years Exp. in ‘scientific writing / clinical documentation’ role preferred KEY RESPONSIBILITIES: Technical writing, literature...

Reporting to: Assistant Manager – Regulatory Affairs Division: Ortho Implants Location: Chennai No. of Positions: 1 Education: B.E/ B. Tech in Biomedical Engineering / M. Pharm Regulatory Affairs Experience: 2 - 4 years Exp. in ‘scientific writing / clinical documentation’ role preferred KEY RESPONSIBILITIES: Technical writing, literature search,...

Why Patients Need You Role title: Extractable & Leachable Scientist Role Description: Design and execution of E&L studies, Impurity identification and Q3D studies **Responsibilities**: - Responsible for 1) Method development, feasibility studies 2) Validation/Scientific protocol preparation and execution 3) Development/Scientific/Validation report...

Why Patients Need You Role title: Scientist - E&L Role Description Design and execution of E&L studies, Impurity identification and Q3D studies **Responsibilities**: - Responsible for 1) Method development, feasibility studies 2) Validation/Scientific protocol preparation and execution 3) Development/Scientific/Validation report preparation 4)...

Why Patients Need You What You Will Achieve Pfizer's Drug Safety Research & Development (DSRD) is a highly innovative, functional and integrated scientific organization committed to the advancement of the overall portfolio. You will be member of a group developing and implementing of the DSRD data strategy. You will collect, organize, process, and curate...

Functions as the Global Product Owner (GPO) or Support GPOs 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 of post approval submissions. - Preparation of...

Our Client**:Vikatan is HIRING!** **Description** **Job Title : Data Scientist** **Experience**: 4 to 7 yrs **Education**: Any UG / PG We are looking for a Data Scientist who will support our product, sales, leadership and marketing teams with insights gained from analysing company data. - They must have strong experience using a variety of data...

Functions as a CMC– Regulatory Strategist working with Global Regulatory Strategists (GRS-CMC) to updated and maintain CMC deficiency database. To do analysis/trending of deficiencies received. Other actives may include working with GRS-CMC and Cross Functional Teams to prepare and submit CMC strategies/ submissions for the assigned activities/products in...

Functions as a CMC – Regulatory Strategist working with Global Regulatory Strategists (GRS-CMC) to updated and maintain CMC deficiency database. To do analysis/trending of deficiencies received. Other actives may include working with GRS-CMC and Cross Functional Teams to prepare and submit CMC strategies/ submissions for the assigned activities/products...

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...

We are looking for Lead Data Scientist with 8 to 15 Yrs of Experience for our esteemed client for Bangalore Location.Key Skills : - ML Model Containerization, ML Model Inference Pipelines. - Strong Python programming, RESTAPI This is an immediate requirement. Roles and Responsibilities :- You would be required to Identify, develop, and implement the...

Functions as the Global Product Owner (GPO) or supports a GPO for Life Cycle Management (LCM), working with Cross-Functional Teams (CFT) to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries. - Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), CTD sections of supplements /...

In Global Data, Insight & Analytics (GDI&A), we aspire to navigate Ford Motor Company through the disruptiveness of the information age, harnessing the power of data and artificial intelligence to realize the enterprise’s known goals, reveal hidden opportunities, and achieve data superiority.The Strategy & Enterprise Analytics team under Connected Vehicle...