Regulatory Affairs Manager; CRO - Remote, West Coast

Overview

Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial pathways. As an emerging global CRO, HiRO collaborates closely with biotech and pharmaceutical companies, aiming to efficiently bridge the gap between laboratory research and market commercialization. Our Team Members are curious and determined, always looking to transform challenges into opportunities. Our mission is to provide cutting-edge and capital-efficient solutions, ultimately benefiting patients worldwide.

Job Title: Regulatory Affairs Manager

Location: US - Remote (West Coast preferred)

• Act as US agent to communicate with FDA on behalf of sponsor, distribute the update in timely manner, guide the team for the response to Information Request (IR) if any.
• Delivery of the project, including but not limited to, preparation/execution of the consultation meeting, IND/NDA with its maintenance, CMC documents authoring/reviewing and gap analysis, different submissions and ad-hoc consultation.
• Maintain a full understanding of the organization’s consulting models and methodologies, as well as good knowledge of what services RAS provides.
• Use technical skills and knowledge of a particular subject and/ or market to proactively work with the team to propose resolutions to possible problems or conflicts.
• Timely performance of work within a project scope and profitability to the quality expectations of RAS and the client.
• When serving as a Regulatory Project Manager or Regulatory Lead, a Consultant assures the work of the entire team is delivered on time and that it meets client’s and RAS’s quality expectations, updates the system in the timely manner, including but not limited to, the time entry, project status, financial related matters (e.g. revenue recognition update, invoice issuance initiation and etc.)
• Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience
• Actively work with cross-functional team to support the business opportunities and commercial activities, including participating in and presenting in the client meeting, seminar, webinar, conference.
• Provide mentoring and guidance to RAS team members on technical discipline(s) and regulatory services to ensure timely project delivery with quality

• Extensive knowledge of FDA regulations, particularly IND submissions, CMC requirements, and regulatory communication strategies.
• Previous CRO, or pharmaceutical experience required.
• Strong computer skills (MS Office Suite: MS Excel, MS Word, MS PowerPoint, MS Teams, MS Outlook, TMF management systems, and Internet).
• Strong background in authoring, reviewing, and performing gap analysis of regulatory documents including INDs, CMC sections, and other submission-related materials.
• Demonstrated ability to manage regulatory projects or programs, ensuring timely delivery, scope alignment, and adherence to quality and financial expectations.
• Familiarity with regulatory consulting models and methodologies, with a focus on client engagement, relationship building, and service excellence.
• Strong written and verbal communication abilities for interfacing with clients, regulatory authorities, and internal teams.

• Bachelor’s degree within the Life Sciences, Clinical Research, or a related field;
  Advanced degree preferred.
• Fluency in oral and written English.
• Excellent problem-solving with sound judgment and decision-making skills.
• Excellent presentation, organization and project management skills.