HiRO - Harvest Integrated Research Organization · 3 days ago
Regulatory Affairs Manager (CRO) - Remote, West Coast
United States
Full-time
Remote
Mid, Senior LevelHarvest Integrated Research Organization (HiRO) is a globally oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial pathways. The Regulatory Affairs Manager plays a critical role in ensuring successful regulatory strategy and execution across a wide range of projects, including direct communication with the FDA, project delivery oversight, and regulatory documentation preparation.
BiopharmaBiotechnologyClinical TrialsMedicalPharmaceutical
Hiring Manager
Ariane Moyer
Responsibilities
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
Qualification
Required
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
Preferred
Advanced degree preferred
Company
HiRO - Harvest Integrated Research Organization
Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative clinical research organization (CRO).
Founded in 2020
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$1.58MKey Investors
OrbiMed
2022-03-17Series A· $1.58M
Leadership Team
Karen Chu
Founder and CEO
Recent News
Panacea Venture
2024-05-13
New Alliance Capital
2024-05-13
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