Regulatory Affairs Specialist (4 to 5 Years Experience)

Company Description

At Novaspire Biosciences, we pride ourselves on being a trusted partner to the pharmaceutical industry, delivering comprehensive, high-quality clinical research services. We specialize in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the drug/product development lifecycle, from clinical studies Phase I to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services & training, and imaging studies. With over 75 years of combined experience, our team provides solutions and streamlined processes to ensure efficient and effective research outcomes.

Key Responsibility:

• Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.

• Manage and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)

• Maintain a strong customer service management approach with clients.

• Lead project teams and advise departments on regulatory standards issues and strategies

• Develop, write, and implement standards and procedures related to regulatory operations.

• Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as required

• Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning.

• Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit.

• Completing other appropriate duties as assigned by line manager that require similar skills

Skills Required:

• Preparation and submission of Clinical Trial application dossier on the Regulatory portal.
• Experience in preparation of Dossier for South African Regulatory, FDA and EMA
• Submission of the dossiers and regular follow up with Regulatory officials till approval.
• Preparation and submission of a dossier for Post Approval changes including Major Protocol Amendment, Minor Protocol Amendment, IB/ICF/CRF notifications, Site Addition, Site closure and PI Changes etc.
• Handled CTRI site and SUGAM portal.
• Experience in eCTD, NeeS, Paper Submissions.
• Experience in EU, US, South Africa, GCC and Canada HA submissions.
• Experience in Lorenz Docubridge and ISI Tool Box
• Experience in sequence building and document level publishing
• Good knowledge on the CTD sections.

Minimum Requirements:

• Minimum 4 to 5 years of working experience working with different countries regulatory officials.

• Excellent communication skills including proficiency in verbal and written English

• Proficiency in Microsoft Word and Excel.