Pharmaceutical regulatory Work, Jobs in Remote (with Salaries)

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FSP Principal Medical Writer (Regulatory) - Client-Dedicated
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Regulatory Affairs Consultant - CMC vax/bio (home or office based)

Parexel -
Remote

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Job details

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
English
Quality assurance
Organisational skills

Full job description

Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This is a client 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 our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for vaccines or biological products.

Primary Tasks & Responsibilities:

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
Assess change controls and provide regulatory assessments of quality changes in production and quality control.
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
Manage projects within all 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 related to technical/CMC/quality, within 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 vaccines or biological processes - must.
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
Team spirit, flexibility, accountability, and organizational skills.
Fluent in English (written and spoken).

#LI-REMOTE

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Refine Your Search

pharmaceutical regulatory jobs in remote

Regulatory Affairs Consultant - CMC vax/bio (home or office based)

Quality Specialist - 18 months FTC

Senior Medical Writer (Regulatory) - Multi-Sponsor

(Associate) Medical Director - Neurology

Per Diem Research Nurse London UK

Associate Director, Regulatory Affairs - UK & Ireland

Analyst II, Domain

Payroll Specialist DACH (m/w/d) - part-time

EU Business Development Director - Commercial Leadership | GMP Labs

Global Program Manager - Development Cloud

Area Sales Manager

Sales Executive, Offensive Security Services Consulting (United Kingdom)

Principal Consultant, Advertising & Promotion Strategy

Senior Consultant - Migration Architect

Sales/Business Development Manager/Director

Clinical Research Associate (CRA)

Clinical Research Associate

Medical Writer

Cosmetic Safety Assessor

FSP Principal Medical Writer (Regulatory) - Client-Dedicated

I want to receive the latest job alerts for pharmaceutical regulatory in remote

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