Regulatory Affairs Associate

**Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...

**_Regulatory Affairs Associate _**: **Experience: RIM**: **Relevant experience in Regulatory and should be willing to work in EU Shifts (12:00 - 9.00 PM)**: - **Experience of handling RIM tools - Veeva Vault specifically.**: - **Basic Regulatory knowledge on regulations and Health Authorities.**: - **Excellent communication skills.** **Knowledge and...

Regulatory Affairs Associate 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.• To provide regulatory input on procedural and CMC documentation...

Senior Regulatory Affairs Associate-Biologics Around 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to...

Regulatory Affairs Consultant.8 years’ experience in handling life cycle management of approved drug products (small molecules) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the planning, preparation (including authoring where relevant)...

Regulatory Affairs Consultant:Around 7-10 years of relevant experience in handling of pre and post approval life cycle management of  drug products (small molecules as well as biologicals) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the...

Regulatory Affairs Consultant:Around 7-10 years of relevant experience in handling of pre and post approval life cycle management of  drug products (small molecules as well as biologicals) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the...

Regulatory Affairs Consultant.8 years' experience in handling life cycle management of approved drug products (small molecules) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the planning, preparation (including authoring where relevant) and...

Regulatory Affairs Consultant:Around 7-10 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologicals) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the...

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 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...

Bengaluru, India **Job ID** 84359BR **Category** Regulatory / Consulting **ABOUT THIS ROLE**: **Experience: Biologic CMC** 2 years of experience Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to: - Understanding of EU/CA/WHO/US regulations & guidance allowing...

**About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...

**Department: Global Regulatory Affairs - GBS - EU Submission Hub** **About the Department** Global Regulatory Affairs (GRA) in Global Business Services (GBS) Bangalore is a global RA hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast, high quality product approvals....

**Department**:RA CMC Biotech and Rare Disease **About the department** Regulatory Affairs plays an important role in ensuring all Novo Nordisk Medicines and Devices developed with compliance and keeping patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs will be involved throughout phases of product...

We’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 39,000...

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

Regulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Global Regulatory Affairs** - Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment?...

**About the department** International Operations Regulatory Affairs Bangalore in Global Regulatory Affairs Global Business Services (GBS) is a global RA hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast, high quality product approvals. The team delivers full strategic...

Department: 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 apply...

Description 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 the...