Regulatory Affairs Consultant CMC vaccines or biologics (home or office based)
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Job Location:
Bloemfontein - South Africa
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 affairs professional looking for a new opportunity We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This role is for a client dedicated project and the role can be home based or office based in Bloemfontein.
As the Regulatory Affairs Consultant you will play a vital role in our companys worldwide post-approval regulatory activities specifically focused on Chemistry Manufacturing and Controls (CMC) for vaccines and/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 - strong plus
Knowledge of vaccines and/or 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).
Required Experience:
Contract
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
