Remote Veeva Jobs – 32 Open Jobs Today

Senior Regulatory Affairs Associate
Parexel —Remote
- Remote
6d
Senior Regulatory Affairs Associate- CMC Biologics
Parexel —Remote
- Remote
- Master's degree
- Bachelor's degree
Sales and Account Partner
Veeva Systems —Remote
- Full-time
- Remote
- Sales
- English
- AI
- Paid time off
- Work from home
CAI Informatica Developer
UHV Software solutions PVT LTD —Remote
- Remote
- Azure
- Salesforce
- Databases
Quick apply
9d
Senior Migration Consultant
Veeva Systems —Remote
- Full-time
- Remote
- Oracle
- Salesforce
- Java
- Work from home
Platform Engineer - Integration Services
Veeva Systems —Remote
- Full-time
- Remote
- English
- Java
- SQL
- Health insurance
- Work from home
Senior Clinical Database Programmer
Parexel —Remote
- Remote
- Java
- SQL
- Business development
7d
Senior Software Engineer - Test Automation (Clinical Platform)
Veeva Systems —Remote
- Full-time
- Remote
- Computer Science
- Java
- Master's degree
- Health insurance
- Work from home

More jobs to discover

Find similar jobs that you might be interested in.

Senior Regulatory Affairs Associate- CMC Biologics
Parexel —Remote
Author CMC components of Annual Reports, renewals (Modules 1, 2, and 3), and GMP-related submissions, including site registrations.

I want to receive the latest job alerts for veeva in remote

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

veeva jobs near remote

Senior Programmer jobs in Remote

Platform Engineer jobs in Remote

Informatica Developer jobs in Tamil Nadu

Software Developer Fresher jobs in Mohali, Punjab

Work From Home Net Developer jobs in Pune, Maharashtra

Informatica Developer jobs in Hyderabad, Telangana

Laravel Developer jobs in Gurgaon Kty., Gurugram, Haryana

Informatica Developer jobs in Bengaluru, Karnataka

Python Developer jobs in Madurai, Tamil Nadu

Informatica Developer jobs in Jhilmil Colony, Delhi, Delhi

Regulatory Affairs Specialist jobs in Kukatpally, Hyderabad, Telangana

Regulatory Affairs Specialist jobs in Malad, Mumbai, Maharashtra

Onboarding Specialist jobs in Bengaluru, Karnataka

Regulatory Affairs Specialist jobs in Borivali, Mumbai, Maharashtra

Regulatory Affairs Specialist jobs in Remote

Senior Programmer jobs in Bengaluru, Karnataka

Senior jobs in Kanpur, Uttar Pradesh

Senior Programmer jobs in Nagar, Uttar Pradesh

Senior Graphic Designer jobs in Chennai, Tamil Nadu

Senior Programmer jobs in Pune, Maharashtra

Senior Regulatory Affairs Associate

Parexel -
Remote

Apply Now

Job details

6 days ago

Full job description

Senior Regulatory Affairs Associate

5+ years experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets.
Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
Working knowledge of EU/US regulatory procedures including post approval requirements.
Experience in handling CMC related health authority queries, and author responses to HA requests
Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
Preparation of documentation for different types of Variation procedures like Super Grouping,
Grouping and Work-sharing to the Marketing Authorizations.
Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
Author CMC components of Annual Reports and renewals (m 1/2/3), GMP submissions e.g., site registrations
Providing regulatory impact assessment for any change control and identification of required documentation for EU/US submissions and other markets.
Liaise closely with cross-functional members with aligned product responsibilities.
Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.
Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault.
Strong communications skills and ability to guide and mentor team members, and ability to work independently.
Authoring content of the label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
Familiarity with EU Guidelines for QRD / Excipients.

#LI-REMOTE

Apply Now

Refine Your Search

veeva jobs in remote

Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate- CMC Biologics

Sales and Account Partner

CAI Informatica Developer

Senior Migration Consultant

Platform Engineer - Integration Services

Senior Clinical Database Programmer

Senior Software Engineer - Test Automation (Clinical Platform)

More jobs to discover

I want to receive the latest job alerts for veeva in remote

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected