Regulatory Affairs Consultant - USA Remote
--Alien Technology Transfer Ltd--
The Alien Technology Transfer Group leads top-class innovators to success by converting visionary ideas into tangible realities. The group is composed of two companies: Alien Innovation Consulting and Alien Venture Studio.
With the financial support of public funding opportunities and strategic private investments, Alien Innovation Consulting champions only impact-driven innovations and supports companies with concrete growth ambitions funding their product development.
Alien Venture Studio is an international Venture Studio that designs, funds, and launches innovative companies through the timely transformation of high-potential concepts into profitable ventures. We nurture companies throughout their entire journey, from inception to seed and early funding rounds, ultimately guiding them in the direction of the successful commercialization of their products and business growth.
Are You ready to experience working for a young, dynamic rapidly growing technology transfer company?
We are looking for a freelance Regulatory Affairs Consultant to join our team!
You will be responsible for supporting our clients - US-based start-ups funded under the Small Business Innovation Research (SBIR) program - by supporting them in navigating the complex landscape of regulatory compliance for new medical devices and pharmaceuticals. Your expertise will be crucial in obtaining regulatory approvals, and ensuring their products meet the highest standards of safety efficacy, and quality, while adhering to applicable laws and regulations.
DUTIES AND RESPONSIBILITIES
Develop and execute regulatory plans to facilitate the successful approval and market launch of new products, including preparing and submitting regulatory submissions to relevant authorities (FDA, etc.);
Advise on reimbursement strategies;
Assist in the preparation and maintenance of regulatory documentation, ensuring compliance with relevant regulations and guidelines;
Participate in meetings and communications with regulatory agencies, acting as a company representative for regulatory matters;
Collaborate with our clients and provide regulatory guidance at any stage of the product lifecycle;
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant compliance standards;
Strong track record of successful regulatory submissions and approvals for medical devices and pharmaceuticals;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Ability to work independently, prioritize tasks, and manage multiple projects;
Proven ability to maintain positive client relationships;
Regulatory Affairs Certification (RAC) is preferred;
Experience working with start-ups is preferred.
Please note: Due to the high volume of candidates we are unfortunately not able to provide individual feedback regarding the outcome of every single application.