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 :

Minimum Requirements :