Ind Jobs

Experienced Regulatory Affairs professional needed to lead preparation and coordination of regional regulatory submissions and labeling for investigational and commercial products at Gilead in Foster City.

Northwestern Medicine seeks a Senior Regulatory Coordinator to lead IRB submissions and regulatory oversight for complex stem cell transplant and cell therapy studies within the Autoimmune Diseases program.

ORIC Pharmaceuticals seeks a Regulatory Affairs Manager to drive timely, compliant regulatory submissions and support clinical oncology programs from its San Diego office.

Outpace Bio is hiring an Associate Director, Manufacturing and CMC to lead external GMP manufacturing partnerships, drive technology transfers, and author CMC content to support advancement of its programmed T cell therapy pipeline.

Lead the CMC function for Pattern Bio’s AAV-based oncology pipeline, building scalable manufacturing, analytical and regulatory strategies from early development to commercialization.

Allucent seeks a seasoned VP, CMC (contractor) to lead regulatory strategy, CMC development, and global Health Authority interactions to accelerate life-changing therapies.

Orchard Therapeutics seeks an experienced VP of Clinical Development to lead global clinical science, design and execute clinical strategies, and represent clinical development in regulatory and cross-functional engagements for its gene therapy programs.

Senior Manager, Biomarker Operational Quality (contract) to lead GxP quality oversight, audits, and metrics for clinical and preclinical biomarker programs supporting Vertex development efforts.

Senior medical writer and team lead role responsible for authoring regulatory submissions and maturing medical writing processes at a growth-stage biotech focused on immunology.

Senior QA executive needed to lead Sirtex's global quality management system, drive FDA and international regulatory approvals for device and drug products, and manage a cross-functional QA organization from the Woburn hybrid office.

Kelonia Therapeutics is hiring a VP of Research to lead viral engineering and advance lentiviral gene therapy programs from target selection to IND while building a best-in-class research organization.

Lead global regulatory strategy and submissions for Telix’s radiopharmaceutical portfolio, driving IND/BLA/MAA filings and agency interactions to support product approvals and international roll-out.

Pfizer is hiring a Principal Scientist in Bothell to lead formulation and physico‑chemical characterization for biotherapeutics, with an initial focus on ADCs and scale‑up to clinical and commercial manufacturing.

Lead analytical strategy and comparability for cell and gene therapies at Bristol Myers Squibb, driving cross-functional alignment, regulatory submissions, and technical governance.

Lead an analytical development team at AbbVie to design and implement robust separation-based methods and regulatory-ready analytical strategies supporting biologics development and GMP testing.

Lead translational and early clinical development for immunology programs at Lilly, driving therapeutic hypotheses, biomarker strategies, and early-phase trials toward transformative treatments for autoimmune and inflammatory diseases.

AbbVie is looking for an experienced CMC Product Group Director to lead cross-functional CMC strategy and project execution for small-molecule and hybrid products across development and commercial stages.

Syneos Health is hiring a Regulatory Consultant CMC to lead CMC regulatory activities, prepare submissions and gap analyses, and support global regulatory strategy in a remote capacity.

Lead global CMC regulatory strategy and submissions for RayzeBio’s radiopharmaceutical development programs, driving IND/IMPD/DMF/NDA/MAA content and Health Authority interactions.

Lead toxicology strategy and preclinical safety evaluation for high-impact global health R&D, guiding investments, due diligence, and cross-functional translation to advance safe, scalable interventions.

Senior clinical leader needed to drive clinical strategy, study design, safety oversight, and regulatory documentation for Kyverna’s cell- and gene-therapy programs in a remote capacity.

Lead and coordinate Pfizer’s early-stage oncology clinical programs from FIH through proof-of-concept, driving protocol development, data review, and cross-functional execution.

Senior-level oncology clinical scientist to co-lead early development programs (FIH to POC) at Pfizer's Collegeville site, working cross-functionally to design, execute and interpret early oncology trials.

An experienced MD leader is needed to drive product concept innovation, prioritize platform-derived therapeutic opportunities, and lead cross-functional teams to accelerate early-stage translation toward clinical candidates.