Regulatory affairs
2 weeks ago
JOB TITLE : Regulatory Affairs - Senior Executive - ROW markets (Philippines, Kenya, Ethiopia, Nigeria) WHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES? As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training that teaches coaching skills, team collaboration, performance enhancement, as well as how to be an effective contributor. At Surgeway Biosciences, we offer much more than just a job. We strive to give you a Promising and Bright Career path. PRIMARY GOAL FOR THE ROLE Complete technical know how about dossiers, and dossier compilation (for ROW markets) - and generating new dossiers and reviewing existing dossiers, in a timely and accurate manner. Roles & Responsibilities: To prepare and compile a registration dossier as per the CTD / ACTD / Country specific guidelines - specifically for ROW markets (Philippines, Nigeria, Zambia, Ethiopia, Kenya, Myanmar, Cambodia,) Must be aware of the contents of a Dossier, and should be knowledgeable about all the documents attached in dossiers To prepare, review /check artwork, pack insert, Sm PC, etc. To verify all technical documents and information received from various departments at the manufacturing site. To verify specification of excipients, active, finished product, and packaging material and all required documents. Must be aware of Biosimilars/Drug products submission procedure for ROW countries Must be aware of the ICH guidelines and the updates on the same To reply to any queries raised by respective regulatory authorities, in a timely manner. Maintains the highest level of submission standards. Requirements: Prefer professionals with experience in Dossier preparation and Submission- for ROW markets (Especially South East Asia and East Africa) Two to Three years’ experience in Pharma Regulatory Affairs will be preferred Immediate Joining or 15-day's Notice Period is preferred. Candidate Profile: M. Pharm candidate with 2-3 years of experience in the RA department ( for ROW countries) Good communication skills in English Ability to grasp new concepts quickly Must have a systematic approach to solving problems. Must be able to understand the techniques and processes used Excellent PC skills, should be proficient with the usage of the internet as a tool to find necessary and useful information. Must be organized- timely, and with information/data.
-
Senior Regulatory Affairs Trainer
24 hours ago
bangalore, India Tek Support Full timeJob Title: Regulatory AffairsLocation: RemoteJob type: Part-timeJob Summary:We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance, submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible for designing and...
-
Senior Regulatory Affairs Trainer
22 hours ago
bangalore, India Tek Support Full timeJob Title: Regulatory Affairs Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance , submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible...
-
(Urgent Search) Head- Regulatory Affairs
2 weeks ago
Bangalore, India Michael Page Full timeAbout Our Client This opportunity is with a global MNC recognized for its contributions to the life sciences industry. Job Description 1. Regulatory Strategy Development- Define and drive the regulatory vision and strategy for CRM products, aligning with company's business goals. 2. Leadership and Team Management- Build and lead a high-performing...
-
International Regulatory Affairs Manager I
2 weeks ago
Bangalore, Karnataka, India AstraZeneca Full timeJob Title International Regulatory Affairs Manager I Global Career Level D1 Introduction to role Within International Regulatory Affairs we take innovative regulatory approaches to bring life-changing medicines to patients in international markets We work across the AstraZeneca pipeline and business to accelerate regulatory approvals for new...
-
Regulatory Affairs Executive
2 weeks ago
Bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialise in market leading technologies that push the...
-
Regulatory & Liaisoning Affairs Officer
2 weeks ago
Bangalore, Karnataka, India Enerparc Energy Private Limited. Full timeAbout Company Enerparc AG is a global expert in developing engineering building and operating ground mount as well as roof mount photovoltaic PV systems As an EPC contractor our company has connected over 3400 MW of solar systems to electricity grids With local presence in all active solar markets like Europe Middle East Asia we are also one of...
-
Bangalore, Karnataka, India BD Full timeSummary This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance This position participates on cross-functional teams leads the development of global regulatory strategies authors regulatory submissions leads interactions with regulatory agencies notified bodies reviews design...
-
Regulatory Affairs Manager Ii
2 weeks ago
Bangalore, Karnataka, India AstraZeneca Full timeAccountabilitiesRegulatory Affairs Management- Contributes to regulatory submission strategy identifying submission risks and opportunities while leading simple through more complex regulatory applications and managing procedures through approval - Provides regulatory expertise and guidance on procedural and documentation requirements to GRET Global...
-
Lead Specialist, Regulatory Affairs
2 weeks ago
Bangalore, Karnataka, India GE Healthcare Full timeSummary Join GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to market Be part of a dynamic environment where your...
-
Regulatory Affairs Associate I
1 week ago
Bangalore, Karnataka, India AstraZeneca Full timeJob Title Regulatory Affairs Associate I Global Career Level C1 Introduction to role Are you ready to be part of the solution turning drug development strategies into reality As a Regulatory Affairs Associate I you ll play a crucial role in obtaining and maintaining licenses and applications ensuring they align with AstraZeneca s standards and...
