The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Pharmaceuticals, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Innovative Science Solutions (ISS) is a leading scientific consulting firm serving the worldwide pharmaceutical, biotechnology, and medical device industries. We are a team of skilled scientific and regulatory consultants that deliver distinctive approaches to fulfill the complex business needs of industry and counsel. Blending scientific expertise and business acumen, ISS integrates strategy, support, and analysis for regulated products to provide results-driven solutions with superior outcomes.
As the Senior Regulatory Consultant, you will play an important role in the management of clients, billable projects, and junior staff. You will be responsible for ensuring that all scientific content is accurate and well organized as well as evaluating and analyzing scientific information to support the underlying integrity of the projects. We will expect you to be an expert at understanding the processes adhered to by pharmaceutical and medical device firms as well as working with scientific data and nomenclature. You must be highly skilled at effectively communicating complex scientific principles to non-scientists, scientists, and physicians.
Manage FDA Advisory Committee Programs: Play a senior management role in projects involving FDA Advisory Committee management, including, leading team meetings, managing project timelines, developing slide decks, and drafting briefing books.
Manage Regulatory Project: Play a senior role in provide guidance to clients relating to drug and medical device safety and efficacy evaluations and activities related to FDA product approvals.
Scientific Summary and Analysis: Review scientific studies and data relevant to a particular scientific issue and provide meaningful written and/or oral critical analysis and integration as to how it affects the client objectives.
Client Interaction: Provide oral and written communication with clients to convey project status, interim reports, and final project deliverables.
Program Management: Supervise client projects and ensure that they are completed with high degree of accuracy and quality and that they are within budget and on time.
Budget Preparation and Oversight: Provide budget estimates for project proposals and ensure that projects stay within budget parameters.
Management and Oversight: Oversees junior staff on client-related projects and administrative responsibilities.
Marketing Initiatives: Conceive, formulate, and implement effective marketing initiatives designed to identify leads and expand project work.
Review and Revise Work Product: Review written work product for clarity and style and revise as necessary.
Expand Projects: Possess ability to identify opportunities to expand existing client projects into larger and more profitable jobs.
As an ideal candidate, you must be inquisitive, ambitious, hardworking and have a strong healthcare regulatory experience as well as experience working for and consulting with the pharmaceutical or medical device industry. You should also have the following skills and qualifications:
Advanced degree preferred in a life science or related field and 2 ? 5 years.
Relevant work experience; preferably in regulatory affairs and/or project management; previous experience with regulatory submissions, regulatory body meetings (e.g. FDA Advisory Committees) a plus.
Proficient and comfortable with scientific/medical data and nomenclature.
Ability to effectively communicate complex scientific and regulatory principles to non?scientists (as well as to scientists and healthcare professionals).
Proficient with Word, Outlook, Excel, and PowerPoint.
Expert skills in internet searching and web browsing related to life sciences and regulatory affairs.
Eagerness to work independently and in teams in a fast?paced environment.
Excellent ability to interpret scientific charts, tables and figures and communicate summary of findings.
Passion for producing and presenting scientific data in oral presentations or written reports.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.
Internal Number: CH1
About Innovative Science Solutions (ISS)
We are a thought-leading health advisory firm, with experts in Science, Insight, Strategy, and Communications delivered as a specialist service or as a fusion of expertise