Senior Regulatory Operations Lead: Submissions & RIM
Parabilis Medicines
Parabilis Medicines is seeking a Senior Manager/Associate Director, Regulatory Operations to lead global regulatory submissions, information management, and publishing initiatives. You will drive Veeva RIM implementations and collaborate across Regulatory Affairs, Medical Writing, Clinical Development, CMC, and Quality to ensure compliant, timely submissions. The role emphasizes strong technical regulatory operations expertise, process improvement, and partnering with external providers. #J-18808-Ljbffr Parabilis Medicines
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...develop and implement regulatory and analytical strategies... ...and collaborate with leading academics in our areas... ...improve HIV clinic operations and patient outcomes,... ...consulting firm).About the Senior Biostatistician... ...supporting regulatory submissions in a pharmaceutical or...SeniorRegulatoryWork experience placementWork at officeLocal areaVisa sponsorship- Anika Therapeutics, Inc. seeks a Regulatory Affairs Project Manager/Sr. Manager to lead cross-functional regulatory programs for pharma, biotech, and medical... ...products. You will own regulatory planning, execution, submission readiness, and program coordination across global...SeniorRegulatory
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...Prime Medicine is a leading biotechnology... ...clinical development and regulatory path, and each... ...Position SummaryThe Senior Manager, Regulatory Operations will plan, coordinate... ...execution of regulatory submissions and program... ...(e.g., Veeva Vault RIM or similar).Proven...SeniorRegulatoryFull timeTemporary work$145k - $175k
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...EGDS Biostatistics Oncology team as Senior Statistical Project Leader (... ...development plans, protocol, SAP, CSR, regulatory documents, studies and submissions activities (when applicable), and... ...processes, and resources to ensure operational excellence and align practices in...SeniorRegulatoryFull time- ...Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...: With some supervision, leads the execution of regulatory CMC investigational... ...the development of robust and accurate submissions. Develops constructive relationships with...SeniorRegulatory
$80k - $200k
...implementation. Veeva’s RIM suite is the... ...fully integrated regulatory information management... ...management, submission publishing, and archival... ...team, the Senior Consultant will be... ...resource planning, leading, and motivating the... ...Affairs, Regulatory Operations, or Pharmacovigilance...SeniorRegulatoryWork at officeLocal areaRemote workWork from home3 days per week- ...Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain... .... This role includes driving global submission planning, coordination, and execution...SeniorRegulatoryFull timeRemote work
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...Director, Business System Owner – Veeva RIM in our Cambridge office. At... ...technology strategy, roadmap, and operational excellence for Takeda’s Veeva Regulatory Information Management platform.... ...aligned to GRIDS and GRA priorities Lead prioritization of system...RegulatoryMinimum wageFull timeWork at officeLocal areaRemote work- ...veterinarians around the world. Job Purpose The Regulatory Affairs Senior Principal Scientist leads and delivers thoughtful, forward-looking regulatory... ..., or oversee regulatory documents, including pre‑submission conference requests, protocol concurrences, and...SeniorRegulatory
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...Kymera is focused on building an industry-leading pipeline of oral small molecule... ...substance, drug product, analytical, quality, regulatory, and supply chain workstreams.Support planning... ...programs through Phase 3, NDA/MAA submission, process validation, and approval.Broad...SeniorRegulatory- ...Vor Biopharma seeks a Senior Manager of Statistical Programming to lead SAS programming efforts for clinical studies... ...completion of clinical trial submissions Requirements Advanced experience... ...or projects Knowledge of FDA regulatory requirements for clinical trial...SeniorRegulatory
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...Assist with all accounting operations including Billing, A/R, A/P,... ...Financial Reporting & Compliance: Lead the preparation and... ...Coordinate the preparation of regulatory reporting.· Research technical... ....· Support government grant submissions and proposals.Qualifications...SeniorRegulatory- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success...SeniorRegulatory
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