Remote Global PV Lead, Biologics Safety & Regulatory
SAB
SAB BIO in the United States is seeking an Executive Director, Pharmacovigilance to lead global safety operations for late-phase biologics and regulatory submissions. The role combines senior scientific leadership with hands-on PV execution in a resource-lean biotech setting. The incumbent will oversee global signal detection, safety data processing, and regulatory documentation (ISS, ISE, DSURs, PSURs), mentor PV staff, manage CROs, and ensure compliance with ICH, FDA/EMA guidelines and #J-18808-Ljbffr
- ...Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions... ...filings. The successful candidate will bring a strong biologics background, strategic leadership, and the ability to...Remote workRegulatory
- ...Scorpion Therapeutics is seeking a Senior Regulatory Affairs leader to oversee global filings and compliance for a late-stage ophthalmic biologic product with FDA approval and European marketing authorization. You will lead end-to-end submissions (BLA, MAA, INDs, CTAs)...Remote workRegulatory
- ...seeking a Senior Director, Global Pharmacovigilance (Safety Physician) to lead worldwide medical safety strategies for biologic products across... ...benefit-risk assessments, and regulatory safety submissions, and provide... ...an MD/DO with 5+ years PV experience, and a proven...Remote workRegulatoryWorldwide
- ...Par Health is seeking a Global Safety Leader (GSL) to oversee medical safety assessment and risk management... .... You will collaborate across Legal, Regulatory, Medical Information, R&D, QA, and commercial teams. Remote eligibility and occasional travel are required...Remote workRegulatoryWorldwide
- ...Manager, Pharmacovigilance (US) to lead PV activities across multiple trials in a remote US setting. You will guide teams, ensure patient safety and regulatory compliance, and drive on-time... ...Ideal candidates have 5+ years of global PV experience, strong PV regulations...Remote workRegulatoryWorldwide
- ...Angitia Biopharmaceuticals seeks a Director of Global Regulatory Affairs to drive regulatory strategy for development programs, coordinating with clinical, CMC, safety, statistics, and operations. You will lead global submissions and health authority interactions, guiding...Remote workRegulatory
$192.4k - $302.39k
...shine? Join us as a Director, Global Medical Lead, Zasocitinib- Psoriatic... ...recognizing local practice, access, regulatory, and stakeholder needs.Model... ...of medical, evidence, safety, regulatory, and reputational... ...accordance with Takeda’s Hybrid and Remote Work policy.Empowering Our...Remote workRegulatoryMinimum wageWork at officeLocal area- ...AstraZeneca seeks a Senior Manager, Safety Scientist to join Global Patient Safety, evaluating and managing safety risks... ...teams. The role emphasizes high ethical and regulatory standards in global practice. You will lead safety data reviews, author or review safety...Regulatory
- Sanofi seeks a Global Safety Officer in Cambridge, MA / Morristown, NJ to lead pharmacovigilance and safety analyses across development... ..., signal detection, and regulatory submissions while collaborating... ...and Health Authorities. MD with PV experience is preferred. Join a...Regulatory
- ...America Pharmaceutical Inc. seeks a Senior Director, Global Medical Safety physician to lead safety strategy for late-stage psychedelic programs and... ...requires deep expertise in neuropsychiatric risk assessment, regulatory safety indicators, and cross-functional leadership...Remote workRegulatory
- ...CSL Behring seeks a Team Lead, Global Regulatory Affairs to drive CMC regulatory strategy for biological and non-biological products. This role collaborates with Global Operations, R&D, and QA to ensure timely, compliant submissions and lifecycle management. Ideal candidates...Regulatory
- ...Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global biologics program. This role will lead CMC activities... .... Local Boston candidates are preferred; remote East Coast candidates will also be...Remote workRegulatoryLocal area
$177k - $278.08k
...class therapies, including ADCs, complex biologics and small molecules. Our goal is to... ...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation...Remote workRegulatoryMinimum wageLocal areaWorldwide- Regeneron Pharmaceuticals, Inc. seeks a Director, Pharmacovigilance Hub to lead local PV execution within our Global Patient Safety Operations team. You will ensure local safety activities meet regulatory requirements and integrate country safety data into the global PV...RegulatoryLocal area
$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, Nephrology in our Cambridge, MA... ...strategies (e.g., Clinical, Commercial, Regulatory, PV, Health Economics and Outcomes, Market... ...in accordance with Takeda’s Hybrid and Remote Work policy.Empowering Our People to ShineDiscover...Remote workRegulatoryMinimum wageWork at officeLocal area- ...positive impact on a global scale. Join our... ...investigating differences in safety outcomes using... ...team? The Lead Biostatistician will... ...pharmacovigilance (PV) and safety-focused... ...studies (PASS) and other regulatory commitments. This... ...Location: Remote from home in the US...Remote jobRegulatoryFull timeWork at officeRelocation package
- ...Elanco is a global animal health leader seeking a senior Advisor, CMC Regulatory Affairs – Biologicals. The role focuses on regulatory guidance, submissions, and interactions to maintain product registrations and availability. Collaboration with Manufacturing, Quality...Regulatory
- ...About Freyr Freyr Inc. is a leading global Regulatory Solutions and Services... ...Location: Princeton, NJ - Remote Job Description Role... ...Affairs, regulatory strategy, safety, medical affairs, advertising... ...-derived therapies and biologics is preferred. ~ Bachelor...Remote workRegulatoryPermanent employmentFull time
- ...Iambic Therapeutics seeks an Associate Director, Drug Safety to lead pharmacovigilance activities and drive regulatory safety deliverables. You will oversee outsourced PV activities and collaborate with Quality, Clinical Operations, and Clinical Development to set up...Remote workRegulatory
- ...to improving lives. With a global workforce, we lead with pride and purpose - prioritizing quality and safety while fostering a culture of... ...safety inquiries from world-wide regulatory agencies. Responsible for... .... WORKING CONDITIONS: Remote eligible Occasional travel may...Remote workRegulatoryWork at officeLocal areaWorldwide
$212k - $333.19k
...proven track record of leading at least 3 discovery... ...programs to clinic, The Global Therapeutic Research... ...include experience with biologics and preferably across... ...pharmaceutical industry, including regulatory requirements and... ...Takeda’s Hybrid and Remote Work policy Takeda...Remote workRegulatoryMinimum wageFull timeLocal areaWorldwide$185.37k - $308.95k
...Director, Medical Review Lead, MSRM Who we are... ...within Medical Safety & Risk Management (... ...medical accuracy, regulatory compliance, and... ...partners closely with Global Safety Leads, Pharmacovigilance... ...Safety Leads, PV Operations, and... ...to be either remote in the US or hybrid...Remote workRegulatoryTemporary workWork from homeFlexible hours3 days per week- ...Therapeutics is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities... ...development. You will integrate disease biology, pharmacology, and clinical data to shape scientific strategy and global CMC approaches. You will lead cross‑...Regulatory
- ...CSL Vifor is seeking a GVP Auditor to execute the global PV audit plan, ensuring safety data accuracy and compliance with regulatory standards. You will audit external partners and internal safety functions, identify non-compliance trends, and help implement corrective...Regulatory
- CSL Behring in King of Prussia, PA seeks a Senior Manager Global Regulatory Affairs CMC—Biological & Non-Biol. Products to lead regulatory strategy and submissions for a dynamic product portfolio. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs...Regulatory
- CSL, headquartered in King of Prussia, seeks a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and non-biological products. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs to meet evolving CMC requirements...Regulatory
- ...seeking a stability program leader to manage global stability activities across product... ...facility. The role collaborates with QA, Regulatory, Development, Manufacturing, and Lab... ...submission. Ideal candidates have a biology/pharma background, strong communication,...RegulatoryRelocation package
- ...Associate Director, Pharmacovigilance to lead global PV projects, ensure regulatory compliance, and drive process improvements in a remote US-based role. You will oversee staff and... ...performance, partner with sponsors, and guide safety reporting across therapeutic areas....Remote workRegulatoryWorldwide
- Scorpion Therapeutics seeks a Senior Director of Regulatory Affairs to oversee global regulatory strategies for biologics development, with a focus on late-stage filings.... ...for global interaction and oversight. You will lead IND, BLA, and sBLA submissions, develop regulatory...Regulatory
$140.8k - $190.49k
...Career Category Safety Job Description... ...career. Global Patient Safety... ...Responsibilities Lead the development... ...with global regulatory requirements. Undertake... ...in the PV System Master File... ...with fully remote teams across time... ...the potential of biology for patients...Remote workRegulatoryFlexible hours
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