Validant is a leading global life-sciences firm specialising in Quality, Manufacturing, Regulatory, Engineering, and R&D services. We blend the best of Consulting and Professional services, Industry and Regulatory leaders, Thought leaders and Tactical support, to create tailored solutions.
These include strategic consulting, program leadership, on-demand expertise, managed solutions, execution level resources, FDA & EMA Compliance, Remediation, Validation & Regulatory Submissions and Project Management.
The Regulatory Specialist will provide direct regulatory support to various projects and products, both new and existing. Responsibilities may include:
Preparing regulatory registration, notification, and pre-market submission requirements, including the necessary regulatory documents. Providing regulatory support for product changes/modifications, labeling, and promotional material review and approval Supporting strategic planning and product development efforts Managing product lifecycle from pre-market to post-marking phase, including reviewing and approving promotional material in compliance with corporate and government requirements Providing regulatory guidance to local business partners and liaising with RA teams
POSITION DUTIES & RESPONSIBILITIES:
Ensures compliance with regulatory agency regulations and interpretations Prepares responses to regulatory agencies' questions and other correspondence Organizes and maintains reporting schedules for new drug application and investigational new drug applications Prepares necessary outputs, including outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope or complexity Conducts searches of existing files for requested information Maintains and archives all regulatory documentation
Functional and Technical Competencies:
Knowledge of FDA Regulations and CE Marking Requirements Proficient with MS Office applications Excellent communication skills (verbal and written) Strong organizational skills Project management skills Problem solving skills Presentation skills
Effectively influences others by partnering with them effectively; persists in the face of challenges. Develops an understanding of relevant competitor products, strategies, and market segmentation. Researches and reports on the Regulatory activities of competitors Listens to and understands others' points of view; develops an understanding of others' motivations, needs and concerns. Manages specific project steps to deliver required objectives independently/or with some supervision or as part of a team (for example, managing individual aspects of regulatory submissions).
EDUCATION & EXPERIENCE REQUIREMENTS:
• Minimum of a B.A. /B.S. within a technical related discipline is required.
• Minimum of 5+ years of experience in Regulatory Affairs
• Ability to work both independently and in a team environment. Ability to problem solve, recognize and find solutions for gaps in processes.