Merck Group

Merck Group is Hiring Specialist - Regulatory Affairs Manager

  • Merck Group
  • Bengaluru
  • B.Sc / M.Sc / B.Pharm / M.Pharm

Job Description

Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations

Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)

Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally

Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoA’s etc.) as well as legalization framework

Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request

Adherence to agreed timelines and proactive communication of any potential risk to the same

Project management and documentation skills, proactive communication approach

Contributor level of experience with RIM, Vault and EDMS 

Minimum 5 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 1 year of Regulatory affairs experience

 

 

Job Overview

  • Posted Date : 07-Oct-2024
  • Location : Bengaluru
  • Qualification : B.Sc / M.Sc / B.Pharm / M.Pharm
  • Experience : 5 Years
  • Company : Merck Group

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Company Information

As a vibrant science and technology company, we believe in science as a force for good. We make a positive difference in millions of people’s lives. Discover how Merck uses science to drive human progress! In Healthcare, we discover unique ways to treat the most challenging diseases, such as multiple sclerosis and cancer. Our Life Science experts empower scientists by developing tools and solutions that help deliver breakthroughs more quickly. And in Electronics, we develop science that sits inside technologies and changes the way we access, store, process, and display information. Everything we do is fueled by a belief in science and technology as a force for good. A belief that has driven our work since 1668 and will continue to inspire us to find more joyful and sustainable ways to live.

 We are curious minds dedicated to human progress. Sound like something you'd like to be part of? Explore and bring your curiosity to life With our “Mobilize for Growth” strategy, we are pursuing a clear ambition. We want to become the global 21st century science and technology pioneer. Our strategy is about unlocking our full potential to take the company to the next level. Our set-up is unique, thanks to our three diverse and distinct sectors, with leading positions in the fastest-growing science and technology markets. By creating superior value for our customers, patients, colleagues and society, we are set to shape some of the most important growth and technology trends of the 21st century. We want to continue accelerating our leading role in science and technology. We aim to increase the Group sales to approximately € 25 billion by 2025. Around 80% of the planned sales growth is to come from the “Big 3” businesses – the Process Solutions business within Life Science, new products from Healthcare, as well as the Semiconductor Solutions business within our Electronics business sector.