Source Job

• Provide strategic regulatory leadership for companion diagnostics (CDx) and precision medicine programs across global markets.
• Lead consulting engagements, guiding clients through FDA, EU IVDR, and international regulatory pathways from development to commercialization.
• Mentor consulting team members and contribute to a collaborative regulatory practice focused on precision medicine innovation.

Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It operates remotely with a focus on efficiency and data privacy.

• Coordinate and track international regulatory submissions for IVD products in the EMEA region.
• Manage regulatory release of products using the GTS tool and ensure compliance with IVD/medical device regulations.
• Collaborate with global teams to document regulatory assessments and oversee channel partner licenses and renewals.

Agilent provides life science, diagnostic and applied market laboratories with instruments, services, consumables, applications and expertise. With 18,000 employees worldwide, the company fosters a culture of trust, respect, integrity, and inclusivity.

• Responsible for submission planning and management of IND-related activities, including annual reports, DSURs, and CTA activities.
• Manages the compilation, QC, and submission of INDs, BLAs, and amendments, and prepares routine regulatory documents.
• Represents Regulatory Affairs on cross-functional teams, providing expertise and managing submission trackers.

Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.

• Leads global regulatory strategy and compliance for Merge Healthcare’s medical imaging portfolio.
• Oversees global product registrations, device licensing, and market authorization activities.
• Provides leadership and expert guidance on emerging regulations and standards.

Merative provides data, analytics, and software for health and social care. It is a medium-to-large company with a remote-first culture and values focus, speed, trust, and inspire.

• Provide strategic regulatory input and manage European Clinical Trial Applications (CTA) and amendments.
• Serve as key regulatory liaison for multi-continental oncology projects, collaborating with cross-functional teams.
• Maintain expertise in GCP, EU regulations, and support business development activities.

Theradex Oncology is a full-service CRO specializing in early and late-phase oncology trials globally. Founded in 1982 with over 40 years of experience, the company has managed more than 250 trials and partners with the National Cancer Institute, maintaining a focused culture on cancer drug development.

• Develop global clinical strategies to support clinical evidence requirements for product submissions.
• Ensure adequate monitoring is conducted on all clinical trials and work directly with regulatory bodies for approvals.
• Select, interface with, and assure training of investigators, physicians, and clinical staff.

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance patients' lives, and supplies high-end niche batteries for specialized markets. We are guided by six Values: Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity, fostering a culture of passionate excellence within our team of over 10,000 employees.

• Lead all operational and lifecycle management aspects of Regulatory CMC submissions supporting cell therapy development programs.
• Develop and execute global regulatory CMC strategies aligned with program objectives and regulatory requirements.
• Serve as Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development.

BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.

• Lead CMC regulatory strategy for small molecule drugs in global Phase 1-3 trials.
• Write and manage investigational regulatory submissions for US, EU, and ROW.
• Support risk mitigation and GMP compliance across development programs.

Recursion is a clinical-stage TechBio company decoding biology to radically improve lives. The company employs a global team and fosters a culture of bold action, care, and collaboration.

• Develop and implement global CMC regulatory strategies for biologic and combination products.
• Prepare and manage CMC submissions, briefing documents, and health authority meeting packages.
• Serve as the CMC Regulatory lead on cross-functional project teams and support health authority interactions.

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is a small, dynamic organization with a collaborative culture and a strong focus on regulatory excellence.

• Lead CMC regulatory activities for IND/CTA development and maintenance to support clinical trials and future MAA/NDA/BLA submissions.
• Prepare and review CMC regulatory documents, assess changes, and collaborate cross-functionally to ensure compliance.
• Represent regulatory on study teams and maintain knowledge of US and international regulations.

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for cancer patients. The company targets the RAS/MAPK pathway and fosters a collaborative, mission-driven culture.

• Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA) and facility registration.
• Coordinate complaint investigations, risk assessments, and field action notifications while ensuring compliance with ISO 13485 and MDR.
• Collaborate with cross-functional teams to prepare documentation, support QMS audits, and maintain regulatory records.

Fujifilm Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, enterprise imaging, and endoscopic/surgical imaging. With over 70,000 employees globally, the company operates in a dynamic, flexible environment that fuels creativity and collaboration.

• Provide strategic regulatory leadership for cell therapy portfolio including commercial readiness and labeling.
• Lead global health authority interactions including FDA, EMA, and negotiations for labeling and approvals.
• Oversee submissions, mentor a high-performing team, and align regulatory strategy with business objectives.

Kyverna is a biotechnology company developing autoimmune cell therapies. As a late-stage organization, it fosters a collaborative culture in a fast-paced, high-growth environment.