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.
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.
Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
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.
Lead safety review and risk management activities for assigned products.
Evaluate safety data from clinical trials, post-marketing sources, and scientific literature.
Support global regulatory submissions and health authority interactions.
Alphanumeric is a company that provides scientific and clinical safety expertise, supporting global organizations in pharmacovigilance and risk management. The company culture emphasizes independent work and collaboration across global teams.
Provide expert regulatory guidance to pharmaceutical and biotech C-suite executives, shaping critical development and portfolio decisions.
Generate new business and meet sales targets while leading complex regulatory engagements and mentoring team members.
Represent Lumanity at industry forums and contribute to practice innovation and thought leadership.
Lumanity is a global strategic partner dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. The company brings together strategy, evidence, engagement, and technology to engineer breakthrough value for biopharma clients.
Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.
The company is a biopharmaceutical organization focused on developing innovative therapies for patients with significant unmet medical needs. It operates as a remote, cross-functional team with a culture emphasizing regulatory excellence, collaboration, and career development.
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 regulatory submission planning, publishing, and lifecycle management for clinical programs.
Serve as SME for eCTD structure, validation, and document management technologies.
Drive process improvements and ensure compliance with Health Authority requirements.
Exelixis is a biotech company dedicated to discovering and developing innovative medicines for difficult-to-treat cancers. With over 25 years of experience, they foster a collaborative and inclusive culture focused on making a difference for patients.
Contribute to regulatory strategies and coordinate interactions with health authorities.
Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.
Provides strategic regulatory support and guidance for advertising and promotional communications for assigned product and disease state.
Serves as regulatory reviewer on Communications and Medical Review Committees, ensuring compliance with health authority regulations.
Collaborates with cross-functional teams to integrate regulatory requirements into promotional materials and conducts training sessions as needed.
Vertex Pharmaceuticals is a biotechnology company focused on developing transformative medicines for serious diseases, including cystic fibrosis and pain. The company is a large, established organization with a collaborative culture that values scientific innovation and regulatory compliance.
Define and oversee Toxicology and Non-Clinical Pharmacology strategies for assigned projects.
Serve as the subject matter expert in Toxicology, managing preclinical safety studies and regulatory interactions.
Ensure translational aspects and safety alerts are integrated into benefit/risk assessments.
A biopharmaceutical company dedicated to developing innovative therapies for rare diseases. With over 1,900 employees in more than 30 countries, Sobi fosters a culture of inclusion and empowerment.
Lead program-level and portfolio-level planning and execution of CMC development for multiple small-molecule assets.
Own detailed CMC project plans and risk registers, partnering with internal and external teams for on-time, within-budget delivery.
Serve as primary point of contact for external CDMOs across China, EU, and US, overseeing manufacturing and documentation timelines.
Enveda is a clinical-stage, AI-enabled biotech company discovering medicines four times faster than the industry standard. The company recently raised $311M in Series E funding and has been recognized as one of America's Best Startup Employers and a Top 100 Most Loved Workplace.
Lead regulatory operations across the portfolio and build/manage the Regulatory Information Management System.
Drive submission planning and execution for regulatory submissions, including DSURs, IBs, and marketing applications.
Establish efficient processes for regulatory records, document management, publishing, and health authority correspondence.
Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The company fosters a casual, collaborative, and entrepreneurial culture in a small or mid-sized biotech environment.
Lead global regulatory strategy for first-in-class small-molecule medicines.
Drive development of submissions and health authority interactions worldwide.
Provide regulatory expertise and mentorship to cross-functional teams.
Enveda is a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than the industry standard. They recently raised over $845M and were named a top workplace with a culture of curiosity and agency.
Drives the US PRC approval process, applying FDA regulations and Viatris policies for promotional review.
Leads cross-functional PRC meetings and coordinates end-to-end operational activities for new product launches.
Manages day-to-day operations, contractors, and training, while serving as subject matter expert on Veeva Vault and VMAP processes.
Viatris is a global healthcare company bridging generics and brands, supplying medicines to ~1 billion patients annually. Headquartered in the U.S. with global centers in Pittsburgh, Shanghai, and Hyderabad, it focuses on empowering people to live healthier at every stage of life.
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.
Develop and implement global regulatory strategies for oncology programs from early development through post-marketing.
Lead preparation and submission of INDs, NDAs, and other regulatory filings to ensure compliance and quality.
Provide strategic regulatory guidance and cross-functional collaboration to drive program success.
Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines for cancer, neurologic and autoimmune disease. They cultivate an inclusive culture that values curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.
Participate in Ro’s cross-functional advertising review process, evaluating creative assets for FDA advertising and promotion compliance.
Review product claims and claim substantiation to assess regulatory risk and level of support required.
Stay abreast of changes in FDA regulations and maintain company-wide advertising guidelines.
Ro is a direct-to-patient healthcare company that provides telehealth, labs, and pharmacy services nationwide. Since 2017, the company has helped millions of patients and is consistently recognized as a top workplace in healthcare, earning multiple honors from Fortune, Great Place to Work, and PEOPLE.