Associate Regulatory Site Officer
il y a 3 semaines
ASSOCIATE REGULATORY SITE OFFICER
- Pharma- AntwerpWHAT IS OFFERED
We offer strong compensation packages that reward your abilities, hard work and resourcefulness in achieving success.
We reward you with competitive salaries and offer a strong package of additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on your seniority, a car may be provided.
We offer personalized training to help you grow in terms of
- What you like to do
- What you are good at
- Where and how you want to make an impact
ABOUT THE COMPANY
MindCapture is a talent company specializing in medical devices, pharma and engineering. As a consultant, you will have the opportunity to learn and sample diverse environments. Moreover, we offer personal and professional support, both from MindCapture and from our partner. For this project, we are working with a global market leader within the pharmaceutical industry.
You will enter a culture where ownership is an essential characteristic of every colleague. We want to excel today but also think about tomorrow and respond proactively. To achieve your work, we need each other, help each other, challenge each other and share knowledge.
**Do you have a passion for regulatory affairs and a strong understanding of CMC documentation?**
We are urgently seeking a knowledgeable and detail-oriented professional to join the Regulatory Site Officer (RSO) team our client. In this critical role, you will play a vital role in supporting the regulatory management of our pharmaceutical product portfolio.
**Responsibilities**:
CMC Dossier Management:
- Manage and review CMC (Chemistry, Manufacturing and Controls) dossiers for various pharmaceutical products.
- Handle tasks related to variations, renewals, annual reports, site registrations, and territory extensions throughout the product lifecycle.
Change Control and Documentation:
- Implement change control updates received from partnered sites into existing regulatory dossiers.
- Collaborate with experts and external partners to prepare associated regulatory CMC documentation for submission to regulatory authorities.
- Analyse the impact of proposed changes on existing regulatory submissions.
Compliance Assurance:
- Review operational documentation and reports to ensure alignment with established regulatory requirements.
REQUIRED COMPETENCES & SKILLS
- Bachelor or master in chemistry, pharmaceutical sciences, bio-engineering, or related discipline within pharmaceutical/biotechnology sciences.
- Proven experience in Chemistry, Manufacturing, and Controls (CMC) processes.
- Solid understanding of regulatory requirements for major markets (US, EU, Japan, China, etc.)
- Experience with a regulatory database system, such as Veeva Vault RIM.
- Excellent organizational skills and meticulous attention to detail.
- Strong communication and project management abilities.
- Demonstrated ability to collaborate effectively across functional teams and diverse cultures.
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