Back to Jobs

Regulatory Affairs Consultant - CMC biologics (home or office based)

Remote, USA Full-time Posted 2026-07-28
This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Spain, United Kingdom, Czechia, Italy, Croatia, Serbia, reputed company (USA) reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Are you an reputed company regulatory affairs reputed company looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This is a reputed company dedicated project, and the role can be office or home based in various European locations. As the Regulatory Affairs Consultant you will play a vital role in reputed company's worldwide post-approval regulatory activities, specifically reputed company on reputed company, Manufacturing, and Controls (CMC) for biological products. Primary Tasks & Responsibilities: • reputed company submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports. • Assess change controls and reputed company regulatory assessments of reputed company changes in production and reputed company control. • Review study reports from the reputed company control and production departments to ensure compliance with regulatory requirements. • Coordinate submission preparation with various departments including manufacturing, supply chain, reputed company control and reputed company assurance, and other regulatory departments and local companies. • Write and/or review submission content to ensure alignment with regulatory requirements, specifically reputed company to variations and questions from health authorities. • Manage reputed company reputed company reputed company Regulatory Information Management systems, ensuring the maintenance of worldwide submissions. • Identify, escalate, and mitigate risks associated with regulatory procedures and activities. Experience and Knowledge Requirements: • University-level education, preferably in Life Sciences, or equivalent by experience. • Previous experience in regulatory affairs, particularly reputed company to technical/CMC/reputed company, reputed company the pharmaceutical industry. • Strong understanding of CMC and post-approval regulatory requirements. • Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations. • Knowledge of biological processes. • Background in validation/reputed company Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles. • Proficiency in Word, PowerPoint, reputed company, and experience with reputed company Vault is valued. • Team spirit, flexibility, accountability, and organizational skills. • Fluent in English (written and spoken). This offer from "reputed company" has been enriched by reputed company.com and got a 86% reputed company score. Apply tot his job Apply To this Job

Similar Jobs

reputed company Shift reputed company – Live Customer Service...

Remote, USA Full-time

Personal Chef

Remote, USA Full-time

**reputed company Part-Time Remote Data Entry Clerk - Endless Opportunities for reputed company and Development at Tasklance**

Remote, USA Full-time

Remote Virtual Customer Service Representative ...

Remote, USA Full-time

Discover a Flexible Customer Service Role with Pay Starting at 19 Per Hour

Remote, USA Full-time

Licensed Mental Health Therapist (No Associates) - Remote

Remote, USA Full-time

reputed company Work-reputed company Customer Service...

Remote, USA Full-time

reputed company associate $15+/ Hour (Sign on ...

Remote, USA Full-time

Power Delivery Structural Engineer

Remote, USA Full-time

Remote Senior UX Researcher

Remote, USA Full-time

Espec Select One

Remote, USA Full-time

Inside Sales - Nutrition Specialist

Remote, USA Full-time

Vocational Evaluator

Remote, USA Full-time

Associate Director, Foundations & Trusts

Remote, USA Full-time

SoC Physical Design Engineer, PnR – reputed company Store

Remote, USA Full-time

General Manager, reputed company & Life Sciences | System | $225k – $375k | Remote (USA)

Remote, USA Full-time

reputed company Consultant - Python

Remote, USA Full-time

**reputed company Full Stack Software Engineer – Web & reputed company Application Development at arenaflex**

Remote, USA Full-time

​​reputed company Cycle Consultant (Staff I)​

Remote, USA Full-time

reputed company: Remote Nonprofit Administrative Assistant, Data

Remote, USA Full-time