
Regulatory Affairs Associate
2 weeks ago
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 appropriate review and compilation of data to appropriate standards & requirements
- Experienced in CTD update/authoring ( CTD Module 1, 2&3)
- Handled and responded Health Authorities Request
- US & CA Annual reports, Renewals, PQVAR, APR
- Assessment of the Change Controls and associated technical dossiers
- Excellent individual project management and communication skills
- Veeva tool experience
**Education**:
Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life
-
Regulatory Affairs Associate
2 weeks ago
Bengaluru, Karnataka, India Planet Science Full time**About Us**: An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO** **Position - Regulatory Affairs Associate.** An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having...
-
Regulatory Affairs Career
2 weeks ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000Job Opportunity: Regulatory Affairs ProfessionalThe role of the Regulatory Affairs Associate I is a vital component in ensuring our products meet regulatory requirements.This includes:Evaluating change controls for registration impact and implementing necessary dossier changes in Europe and International Markets.Key Responsibilities:Compile variation...
-
Regulatory Affairs Associate
2 weeks ago
Bengaluru, India Antal International Full timeJob Description **Job Title**: Regulatory Affairs Associate **Department**: Regulatory Affairs and Quality Compliance **Position at**: Bangalore **Position’s Objective & Summary**: Self-starter, executes the Regulatory strategy for obtaining registration approval of the company portfolio, according to plan. With limited supervision, coordinates and...
-
Regulatory Affairs Associate I
4 days ago
Bengaluru, Karnataka, India AstraZeneca Full time**Job Title: Regulatory Affairs Associate I** **Career Level - C** **Introduction to Role**: **Accountabilities**: As a Regulatory Affairs Associate, you will be responsible for document management, including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements. You will maintain...
-
Associate Staff Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India BD Full timeSummary 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 development of global regulatory strategies authors regulatory submissions leads interactions with regulatory agencies notified bodies reviews design...
-
Regulatory Affairs Manager
6 days ago
Bengaluru, India ITC Full timeRegulatory Affairs Manager ITC Foods Location: Bangalore Experience: 10+ years We are looking for a seasoned Regulatory Affairs Manager to join our team at ITC Foods. Key Responsibilities: Lead regulatory compliance for food products across the US (FSMA, 21 CFR, USDA including NOP), EU, GCC and other international markets which includes Regulatory and Food...
-
Associate Staff Regulatory Affairs Specialist
3 weeks ago
Bengaluru, Karnataka, India CR Bard Full timeJob DescriptionJob Description SummaryThis 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 development of global regulatory strategies, authors regulatory submissions, leads interactions with regulatory agencies/notified...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 90,00,000 - ₹ 1,20,00,000Job OpportunityWe are seeking an experienced professional to join our team as a Regulatory Affairs Specialist.The successful candidate will be responsible for managing regulatory compliance, ensuring adherence to industry standards, and providing guidance on regulatory requirements.This is an exciting opportunity for someone looking to advance their career...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, India Biocon Biologics Full timePosition SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, India Biocon Biologics Full timePosition Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations...