Regulatory Affairs Associate I
4 weeks ago
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
How you’ll spend your day
Assessment of change controls for registration impact and implementation of all necessary dossier changes in; Europe and International Market Responsible for compilation of the variations for the products in the product portfolio in collaboration with other stakeholders Compiling variation packages Experienced in managing, regulatory database and Trackwise.
Your experience and qualifications
Qualification:
Academic degree- and thinking level with a chemical/pharmaceutical background.
Experience:
2-5 years of experience in CMC Regulatory Affairs; Mainly in Europe and International Market Knowledge on registration procedures and pharmaceutical regulations Interest and capability to work with different software, including Document Management System Accurate, able to prioritize and work according to agreed timelines. Working independently with a moderate level of guidance and direction. Solve complex problems using existing solutions and support. Identify & implement process improvements. Team player-
Regulatory Affairs Manager I
4 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...
-
Regulatory Affairs Manager I
4 weeks ago
bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...
-
Regulatory Professional I
1 day ago
bangalore, India Novo Nordisk Full timeDepartment: RA Submission Systems Development Are you passionate about ensuring compliance and streamlining regulatory processes in the dynamic field of life sciences? Do you have a passion for regulatory affairs and a desire to shape the future of the industry? We are looking for a Regulatory Process Expert to join the team implementing...
-
Associate Regulatory Specialist
5 days ago
bangalore, India Novo Nordisk AS Full timeDepartment: Regulatory Affairs Rare Endocrine Disorders Job Level: 7 Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory...
-
Regulatory Affairs
4 weeks ago
bangalore, India AstraZeneca Full timeDescription The Regulatory Affairs Manager 1 with Business Development role sits in the Regulatory Business Development group and is of key importance in the delivery of AstraZeneca business development portfolio to ensure license transition in the most efficient and customer focused manner. The role comprises of two main accountabilities,...
-
Regulatory Affairs
1 month ago
Bangalore, India AstraZeneca Full timeDescription The Regulatory Affairs Manager 1 with Business Development role sits in the Regulatory Business Development group and is of key importance in the delivery of AstraZeneca business development portfolio to ensure license transition in the most efficient and customer focused manner. The role comprises of two main accountabilities, described...
-
BI&A Associate Director, Medical Affairs
4 weeks ago
bangalore, India Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. LCCI Business Insights & Analytics Associate Director, Medical Affairs Analytics At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our...
-
Regulatory Specialist
2 weeks ago
bangalore, India Novo Nordisk AS Full timeDepartment: Regulatory Affairs Rare Endocrine Disorders Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory strategies? We...
-
Regulatory Professional II
1 month ago
bangalore, India Novo Nordisk AS Full timeDepartment: Labelling Operations Are you skilled in graphic design and have experience in regulatory affairs? Are you ready for the next step in your career? We are looking for a Regulatory Professional II to join our Global Regulatory Affairs team in Novo Nordisk. If you have a passion for design and ensuring regulatory compliance, read on and...
-
Regulatory Affairs Manager
1 week ago
bangalore, India PSI CRO Full timeJob DescriptionYou will focus on leading regulatory services for global research projects of novel medicinal products in India while joining our global team of regulatory and ethics submissions experts. Join our team and contribute to groundbreaking clinical research. Office-based in Bangalore Oversee preparation of clinical trial submission dossiers for...
-
Regulatory Affairs Manager.
1 week ago
bangalore, India PSI Full timeJob Description You will focus on leading regulatory services for global research projects of novel medicinal products in India while joining our global team of regulatory and ethics submissions experts. Join our team and contribute to groundbreaking clinical research. Office-based in Bangalore Oversee preparation of clinical trial submission...
-
Regulatory Adherence Associate
4 weeks ago
bangalore, India F335 Deutsche India Private Limited, Bangalore Branch Full timeDescription The Regulatory Adherence Associate will be responsible for the governance of Regulatory Assurance and Reporting across CB, IB and CRU including supporting the delivery of risk and control initiatives and participating in risk and control activities. They will work closely with Operations across multiple products and locations to ensure...
-
Public Affairs Manager
3 weeks ago
bangalore, India Xiaomi India Full timePosition: Manager - Public AffairsLocation: BangaloreJob Responsibility:The role will be responsible for managing Xiaomi's reputation in the Government and amongst Industry stakeholders and executing various initiatives to for stakeholder management and confidence building. The role operates at the intersection of Policy advocacy, Corporate PR and...
-
Senior Regulatory Professional
4 weeks ago
bangalore, India Novo Nordisk AS Full timeDepartment: Regulatory Affairs Rare Blood Disorders Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight...
-
Associate Regulatory Professional II
2 days ago
bangalore, India Lifelancer Full timeThe position As Associate Regulatory Professional II, you will play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines. Your responsibilities will include: Working closely with various submission teams across the organization and all countries in Europe. Managing initial clinical trial application...
-
Regulatory Affairs Consultant
1 day ago
bangalore, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. 8+ years’ experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market. Good understanding of regulatory framework, including regional trends, for various types of...
-
International CMC RA Associate Director
3 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: International CMC RA Associate Director. Career Level - E Introduction to Role: Join us at AstraZeneca as an International CMC RA Associate Director. In this role, you will be responsible for providing the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and product ranges...
-
International CMC RA Associate Director
3 weeks ago
bangalore, India AstraZeneca Full timeJob Title: International CMC RA Associate Director. Career Level - E Introduction to Role: Join us at AstraZeneca as an International CMC RA Associate Director. In this role, you will be responsible for providing the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and product ranges...
-
Regulatory Professional I
2 weeks ago
bangalore, India Novo Nordisk AS Full timeDepartment: EU Submissions Hub Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. We are looking for a dedicated EU Submission Lead for Clinical Trials to...
-
Public Affairs Manager
7 days ago
Bangalore City, India Xiaomi India Full timePosition: Manager Public AffairsLocation: BangaloreJob Responsibility:The role will be responsible for managing Xiaomi's reputation in the Government and amongst Industry stakeholders and executing various initiatives to for stakeholder management and confidence building. The role operates at the intersection of Policy advocacy, Corporate PR and...