Oversee regulatory labeling activities throughout the product lifecycle, from initial assessments to post-approval updates.
Evaluate regulatory changes, coordinate product information revisions, and prepare Health Authority submissions.
Collaborate with cross-functional teams to maintain compliance with evolving regulatory requirements.
A global clinical research organization dedicated to improving patient outcomes through regulatory affairs and medicinal product compliance. It fosters a collaborative, patient-focused culture with opportunities for professional development.
Develop and manage complex clinical product initiatives, including clinical criteria and product roadmaps.
Analyze market information, clinical guidelines, and member claims data to support clinical product management strategies.
Collaborate with leadership and cross-functional partners to execute product strategy and represent the Clinical department in customer sessions.
Prime Therapeutics is a pharmacy benefit manager (PBM) focused on reimagining pharmacy solutions to simplify health care. It is a large, purpose-driven organization that values diversity, inclusion, and equal opportunity.
Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.
Own drug substance technology transfer, MSAT, and manufacturing oversight for CDMO partners.
Lead process validation, commercialization, and lifecycle management for peptide DS manufacturing.
Build and develop high-performing teams while ensuring cGMP compliance and regulatory readiness.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence and is expanding its team.
Serve as operational owner for commercial manufacturing performance at assigned CDMO partners, ensuring reliable execution of production schedules and supply commitments.
Lead a cross-functional Virtual Manufacturing Team to align manufacturing, quality, supply chain, and other functions around a common operational plan.
Drive operational excellence by establishing performance metrics, monitoring trends, and partnering with CDMO leadership to improve manufacturing reliability and compliance.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. The company values trust, ownership, curiosity, and results, with a focus on diversity and inclusion, and offers a collaborative and inspiring work environment.
Coordinate clinical trial site activities and support successful site start-up and activation.
Serve as a primary point of contact for investigative sites, facilitating communication among clinical teams, sponsors, CROs, and regulatory stakeholders.
Ensure compliance with ICH/GCP guidelines, manage essential documentation, regulatory submissions, and site activation milestones.
This role is listed on behalf of a partner company in the clinical research sector, focused on coordinating site start-up and activation for clinical trials. The culture emphasizes operational excellence, collaboration, and patient safety, with a remote working environment.
Coordinate planning, implementation, and delivery of device logistics projects for eCOA clinical trials.
Oversee budgets, deployment plans, and risk mitigation while collaborating with clinical teams and stakeholders.
Ensure inventory management, mobile device management, and global shipping are completed on schedule and within scope.
The hiring company is a life sciences organization specializing in device logistics and electronic clinical outcome assessments for clinical trials. They foster a collaborative, cross-functional remote culture aligned with US East Coast time zones.
Lead formulation and process development for inhaled dry powder products through scale-up and commercialization.
Apply Quality by Design principles and statistical tools to ensure product quality and regulatory compliance.
Collaborate with cross-functional teams and external CDMO partners to deliver CMC milestones and regulatory submissions.
Pulmovant is a biotechnology company developing inhaled dry powder therapies for serious pulmonary diseases. It is a lean, collaborative organization focused on bringing innovative treatments to patients with significant unmet medical needs.
Own the innovation intake queue and stage-gate process, driving concepts from feasibility to go/no-go recommendations.
Manage end-to-end commercialization of novel products, including vendor sourcing, financial modeling, and regulatory due diligence.
Act as the buffer between exploration and core team, ensuring fast, evidence-based decisions with disciplined kill criteria.
BiOptimizers helps people go from baseline health to peak biological performance through science-backed supplements and wellness tools. As a remote-first company, their globally distributed team focuses on clarity, autonomy, and operational excellence.
Manage prior authorization requests and coordinate specialty medication processes for a fully remote healthcare team.
Act as a liaison between pharmacies, prescribers, members, and vendors to resolve complex medication-related issues.
Support single case agreements, member financial assistance, and compliance with contractual and regulatory requirements.
The hiring company is a healthcare organization that administers specialty pharmacy and medical benefit programs. It operates fully remotely, fostering a collaborative and customer-focused culture that prioritizes compliance, member support, and process improvement.
Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.
Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.
Lead CMC workstream planning across multiple development programs, from technical development through regulatory submission.
Build integrated CMC timelines in Smartsheet and coordinate with CDMO partners on tech transfers and manufacturing.
Manage risks, budgets, and cross-functional technical operations teams to drive decisions and ensure on-time delivery.
Kailera is a biopharmaceutical company developing novel therapies for obesity and related conditions. It fosters an entrepreneurial, team-oriented culture and is committed to building an inclusive workplace.
Verify prescriptions for clinical accuracy and safety.
Provide proactive patient counseling via phone and digital platforms.
Collaborate with prescribers and supervise technicians for optimal outcomes.
Blink Health is a healthcare technology company that builds products to make prescriptions accessible and affordable. They are a highly collaborative team inventing new ways of working.
Lead analytical development and control strategy for sterile injectable/parenteral products from development through commercialization.
Define analytical CMC strategies and regulatory submissions, including NDA Module 3 content and specifications.
Oversee stability programs, method lifecycle management, and external CDMO and contract laboratory execution.
Kailera is a biopharmaceutical company advancing novel therapies for obesity and related conditions. The company is an inclusive, team-oriented workplace with an entrepreneurial spirit focused on collaboration, integrity, and excellence.
Manage global regulatory affairs activities for Spyre's IBD program, developing strategies to enable clinical trials and marketing applications.
Lead preparation and submission of regulatory applications to FDA, EMA, and other global health authorities, ensuring timely approvals.
Collaborate cross-functionally with research, clinical, and technical teams to integrate regulatory considerations and mitigate risks.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies. It is a young company with a fast-paced, dynamic culture focused on advancing meaningful medicines for patients.
Provide clinical pharmacology expertise for regulatory submissions and development documentation.
Lead analysis, interpretation, and reporting of clinical PK/PD data for assigned projects.
Collaborate across functions and oversee CROs to support clinical development milestones.
They are a clinical-stage biotechnology company developing innovative therapies for rare and inherited diseases. They operate with a collaborative, cross-functional team culture centered on rigorous science and patient-focused development.
Oversee contract development and manufacturing organizations for drug substance process chemistry activities, focusing on late-stage and validation.
Author and manage RFP documents, support regulatory submissions, and provide technical expertise for manufacturing scale-up and troubleshooting.
Interface proactively with CMC team members and communicate process chemistry strategies effectively across departments.
BridgeBio pioneers a 'moneyball for biotech' approach, pooling projects and early-stage research from academia to reduce risk and develop life-changing medicines for rare diseases. The company fosters a culture of curiosity and experimentation, empowering teams to push boundaries and achieve the impossible.
Own CMC strategy and execution across the full portfolio, spanning drug substance, drug product, device/combination products, and oral solid dose formulations.
Lead process development, scale-up, technology transfer, and regulatory submissions for CMC and device sections to support global filings.
Build and mentor a high-performing CMC and device engineering organization while partnering cross-functionally with Regulatory, Quality, Clinical, and Commercial teams.
Kailera Therapeutics is a late clinical-stage biotechnology company advancing a pipeline of GLP-1-based therapies for obesity and related conditions, including injectable and oral candidates in global trials. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence as it scales toward commercial launch.
Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.
A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.
Manage end-to-end supply chain vendors for outsourced drug substances and finished goods.
Coordinate vendor schedules to ensure GXP-compliant manufacturing of controlled substances.
Oversee vendor performance, contract negotiations, and risk assessments.
Compass Pathways is a biotechnology company dedicated to unlocking new treatment options in mental health care. Headquartered in London with a US office, it leads one of the largest classic psychedelic clinical programs for treatment-resistant depression and PTSD.