Regulatory Affairs Manager - CMC biologics various European locations
Regulatory Affairs Manager - CMC biologics various European locations
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Salary Not Disclosed
1 Vacancy
Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Are you an experienced regulatory professional looking for a new opportunity We are currently seeking a talented CMC Regulatory Manager (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 CMC Regulatory Manager you will play a vital role in our companys worldwide postapproval regulatory activities specifically focused on Chemistry Manufacturing and Controls (CMC) for biological products.
Primary Tasks & Responsibilities:
Develop submission strategies and plans for postapproval 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:
Universitylevel 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 postapproval regulatory requirements.
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
Knowledge of biological processes.
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). French Italian and German would be a strong plus.
Required Experience:
Manager
Employment Type
Full-Time
