16/05/2023
We have an exciting new job opportunity at NOVAX PHARMA/VITEVAX PHARMA! We are looking for a Regulatory and Quality Manager. Please send your résumé/CV and Cover Letter at info@novaxpharma.com
Responsibilities, including but not limited to:
Provide scientific support to lead development of regulatory strategies;
Help with planning, preparing and reviewing regulatory documentation to ensure its suitability for submission to health authorities;
Prepare and submit regulatory submissions to notified bodies as required for global approvals for technical dossiers related to MDD/MDR;
Define, implement and organize action plans to ensure the quality of the company's products and services;
Ensure of the quality system stages of development, make sure of the quality of the providers and suppliers and their regulatory compliance;
Contribute to cross-functional projects in partnership with internal stakeholders (R&D, Marketing, Procurement, Legal, Finance, Business).
Stay up-to-date with EU and Non-EU regulatory requirements and guidelines.
Support with cosmetic products creation and follow-up from a regulatory and compliance perspective.
Manage and maintain continuous improvements within the R&D department.
Create and deliver training programs and development activities that are in align with regulatory guidelines.
· Provide leadership with the planning and ex*****on of projects within the R&D department.
Full job description available upon request: info@novaxpharma.com
Qualifications
· Bachelor’s degree or Master’s or PhD degree in biological sciences, biotechnology, pharmacology, chemistry.
· Good working knowledge of the MDR, ISO standards. Previous work experience in the pharma or medical device.
· At least 5+ Years Experience with regulatory affairs.
· Equivalent experience across Medical Device regulations and relevant biopharmaceutical development experience (e.g. Pharmaceutical Development, Analytical Development, Process Development, Quality Assurance, or Quality Control) will be considered.
· Speaks English Fluently (B2). Italian is an asset.
· Excellent writing and speaking skills, and ability to deliver reports and minutes.
· Proficient with Microsoft Office.
· Project Management skills. Ready to embrace a culture of flexibility and innovation, patient centric with a very high degree of urgency.
· People skills.
· Known as a respectful, supportive and solution-oriented team player, with highly effective organizational and planning skills to apply daily in a multidisciplinary and matrixed environment.
· Character: Systematic, Logical, Ethical, Direct, Independent, Outgoing, Curious, Challenging.
