Regulatory Affairs Consultant

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: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 BA**: **Category**: Software Development/ Engineering **Main location**: India, Karnataka, Bangalore **Position ID**: J1122-2759 **Employment Type**: Full Time **Position Description**: - Requirement Regulatory Affairs BA - Recruiter Name Nikitha - Njoyn ID J1122-2759 - Primary Skills Regulatory Affairs BA - Secondary Skills Pharma...

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...

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...

**_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...

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...

When our values align, there's no limit to what we can achieve.   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...

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...

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...

When our values align, there's no limit to what we can achieve.   Job Description: Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets  with focus on EU countries . Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor...

**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...

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 the department** Regulatory Affairs play an important role in ensuring that all new Novo Nordisk treatments and devices are developed with compliance and the patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs are involved throughout all phases of product development and roll-out. Our people in...

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...

Regulatory Professional I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Global Regulatory Affairs**Position**- Furthermore, in the role you will also handle: - Compile, review and submit pre-meeting packages for authority meetings. - Handle change requests. - Submission of regulatory files, response to...

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...