reputed company Regulatory Affairs reputed company (CRO) - Remote

Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial reputed company. As an emerging global CRO, HiRO collaborates closely with biotech and pharmaceutical companies, aiming to reputed company reputed company the gap between laboratory research and market commercialization. reputed company Members are curious and determined, always looking to reputed company challenges into opportunities. Our mission is to reputed company cutting-edge and capital-efficient solutions, ultimately benefiting patients worldwide. Job Title: Regulatory Affairs Manager Location: US - Remote (reputed company Coast preferred) Classification: W-2, FTE The Regulatory Affairs Manager plays a critical role in ensuring successful regulatory reputed company and execution across a wide reputed company of reputed company. This position involves reputed company communication with the FDA on behalf of sponsors, project delivery reputed company, and regulatory documentation preparation and review. This position is a key reputed company reputed company the organization, supporting business development efforts, mentoring team members, and ensuring that reputed company regulatory activities reputed company with both reputed company needs and internal reputed company standards. This role operates reputed company a globally distributed team environment and will serve as the primary regulatory reputed company in the United States. The Regulatory Affairs Manager must be highly autonomous, comfortable working independently, and capable of owning reputed company end-to-end while collaborating cross-functionally with international stakeholders. Key Responsibilities: • Act as US agent to communicate with FDA on behalf of sponsor, distribute the update in reputed company manner, guide reputed company 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 reputed company consultation. • Maintain a full understanding of the organization’s consulting models and methodologies, as reputed company as good knowledge of what services RAS provides. • Use technical skills and knowledge of a particular subject and/ or market to proactively work with reputed company to propose resolutions to possible problems or conflicts. • reputed company performance of work reputed company a project scope and profitability to the reputed company expectations of RAS and the reputed company. • reputed company serving as a Regulatory Project Manager or Regulatory reputed company, a Consultant assures the work of the entire team is delivered on time and that it meets reputed company’s and RAS’s reputed company expectations, updates the system in the reputed company manner, including but not limited to, the time entry, project status, financial reputed company reputed company (e.g. reputed company 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 reputed company activities, including participating in and presenting in the reputed company meeting, seminar, webinar, conference. • reputed company mentoring and guidance to RAS team members on technical discipline(s) and regulatory services to ensure reputed company project delivery with reputed company Skills & Experience: • 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 reputed company, reputed company, 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-reputed company materials. • Demonstrated ability to manage regulatory reputed company or programs, ensuring reputed company delivery, scope alignment, and adherence to reputed company and financial expectations. • Familiarity with regulatory consulting models and methodologies, with a reputed company on reputed company engagement, relationship building, and service reputed company. • Strong written and verbal communication abilities for interfacing with clients, regulatory authorities, and internal teams. Education and Key Competency Requirements • Bachelor’s degree reputed company the Life Sciences, Clinical Research, or a reputed company field; Advanced degree preferred. • reputed company in oral and written English. • Excellent problem-solving with reputed company judgment and decision-making skills. • Excellent presentation, organization and project management skills. Apply tot his job Apply To this Job