Regulatory Affairs Specialist-API

Bioconbangalore, karnataka, in

16 days ago

Job description

Role Summary / Key Responsibilities

DMF compilation and submission to global markets
Handling post approval submission and CIP assessments
Submission of DMF amendment & response to Health Authority queries
Providing customer support
Evaluating change control assessment
Providing Regulatory input for New molecule development activities
Maintaining Regulatory data base

Qualification : M.Sc. / M. Pharm

Exp : 10 years - 16 years

Create a job alert for this search

Regulatory • bangalore, karnataka, in

Related jobs

Promoted

Regulatory Affairs Specialist-API

BioconBengaluru, Karnataka, India

Role Summary / Key Responsibilities.DMF compilation and submission to global markets.Handling post approval submission and CIP assessments. Submission of DMF amendment & response to Health Authority ...Show moreLast updated: 16 days ago

Promoted

Regulatory Affairs Specialist - Peptides Or Injectable

BioconBengaluru, Republic Of India, IN

Formulation Regulatory Affairs - for Peptide products or Injectables.Level - Deputy Manager / Associate Manager.Formulation Regulatory Affairs for Peptide products or Injectables.Drafting controlled...Show moreLast updated: 15 days ago

Promoted

Associate Staff Regulatory Affairs Specialist

ConfidentialBengaluru / Bangalore, India

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 devel...Show moreLast updated: 30+ days ago

Promoted

Regulatory Affairs Specialist - Peptides or Injectable

BioconBengaluru, Karnataka, India

Promoted

Regulatory Reporting Specialist

ConfidentialBengaluru / Bangalore, India

Morgan Wealth Management is a global leader in investment and wealth management, serving institutions, high-net-worth individuals, and retail investors worldwide. As a Transaction Processing Special...Show moreLast updated: 6 days ago

Promoted

Api Regulatory Affairs - Dmf Filing

Biocon LtdBengaluru, Republic Of India, IN

API Regulatory Affairs - DMF Filing / Compilation (Global market).Level - Assistant Manager / Deputy Manager / Associate Manager Level : -. Hands on Regulatory Affairs-API / DMF Filing / DMF Compilation / Su...Show moreLast updated: 15 days ago

Promoted

Regulatory Affairs Manager I

ConfidentialBengaluru / Bangalore, India

Job Title : Regulatory Affairs Manager I.Are you ready to be part of a team that transforms drug development strategies into reality. The Regulatory Affairs Manager I is a regulatory specialist with ...Show moreLast updated: 6 days ago

Promoted

Regulatory Affairs Specialist – (APAC & RoW)

vueverse.Bangalore, IN

Regulatory Submissions & Compliance.Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, ...Show moreLast updated: 1 day ago

Promoted

Regulatory Affairs Associate II

ConfidentialBengaluru / Bangalore, India

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 countr...Show moreLast updated: 6 days ago

Promoted
New!

Senior Manager Regulatory Affairs

One of the Leading Surgical solutions and Medtech CompanyBengaluru, Republic Of India, IN

Our client is one one of the pioneers and trusted surgical solutions and medtech companies.They export to more than 80 countries worldwide and collaborate with hospitals, governments, and healthcar...Show moreLast updated: 14 hours ago

Promoted

Senior Regulatory Affairs Specialist

ConfidentialBengaluru / Bangalore, India

We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team.In this role, you will be responsible for development and execution of CMC regulatory ...Show moreLast updated: 6 days ago

Promoted

Regulatory Affairs Specialist

ConfidentialBengaluru / Bangalore, India

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.Developme...Show moreLast updated: 30+ days ago

Promoted

Lead Specialist, Regulatory Affairs - WHXR

ConfidentialBengaluru / Bangalore, India

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 regula...Show moreLast updated: 6 days ago

Promoted

Regulatory Affairs (Executive), Plant Health

Sea6 Energy Pvt Ltd.Bengaluru, Karnataka, India

At Sea6 Energy we envision a future where we can harness the potential of the oceans – to provide sustainable solutions in energy, agriculture and food. To accomplish this, a multidisciplinary team ...Show moreLast updated: 12 days ago

Promoted

Regulatory Affairs Specialist-Api

BioconBengaluru, Republic Of India, IN

Promoted

Regulatory Affairs Specialist –

vueverse.Bengaluru, Republic Of India, IN

Promoted

API Regulatory Affairs - DMF Filing

Biocon Ltdbangalore, karnataka, in

Promoted

Regulatory Affairs Executive

Halma plcbangalore, karnataka, in

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...Show moreLast updated: 30+ days ago