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
- A leading pharmaceutical company is looking for a Medical Writing Operations Manager to ensure high-quality, submission-ready documents. The role includes reviewing and formatting documents... ...field and at least 4 years of regulatory document experience in biotech or pharma...SeniorRegulatoryContract work
- Beam Therapeutics is seeking a Regulatory Director/Sr. Director Regulatory CMC to lead global regulatory CMC submissions and ensure compliant health authority communications. The role sits within Regulatory and partners with cross-functional teams to shape strategies for...SeniorRegulatory3 days per week1 day per week
- A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis...SeniorRegulatory
- ...Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract... ...mentor junior staff, and collaborate across functions to ensure timely, high-quality submissions. #J-18808-Ljbffr Alnylam PharmaceuticalsSeniorRegulatoryContract work
- Amylyx Pharmaceuticals is seeking a Senior Manager of Pharmacovigilance Operations to lead day-to-day PV activities for both investigational and marketed products... ...supervision, process improvement, and ensuring regulatory compliance across global PV programs. #J-18808-...SeniorRegulatory
- Treeline is seeking a Senior Clinical Trial Manager with oncology-focused Clinical Operations experience to join our growing Clinical Development group. This role reports... ...CRO activities to ensure compliance with ICH/GCP, regulatory rules, and SOPs; #J-18808-Ljbffr TreelineSeniorRegulatory
- Planet Pharma is seeking a Senior Clinical Trial Manager in the Cambridge, MA area to oversee operational aspects of clinical studies from... ...vendors, and may serve as Lead CRA as needed. The role requires... .../pharma experience, strong regulatory knowledge and excellent communication...SeniorRegulatory
- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The... ...with cross-functional teams. This mid-senior position focuses on ensuring timely, compliant...SeniorRegulatoryFull time
$145k - $175k
...medicines. The company's lead investigational medicine... ...a highly skilled Senior Manager/Associate Director, Regulatory Operations to support and help drive... ...supporting global regulatory submissions, regulatory information... ...and optimization of Veeva RIM Basics while helping...SeniorRegulatoryShift work$195k - $255k
...develop and implement regulatory and analytical strategies... ...and collaborate with leading academics in our... ...that improve HIV clinic operations and patient outcomes,... ...consulting firm). About the Senior Biostatistician... ...supporting regulatory submissions in a pharmaceutical or...SeniorRegulatoryFull timeWork experience placementWork at officeLocal areaVisa sponsorship- Xenon Pharmaceuticals Inc. in Needham/Boston, MA seeks a Senior Manager, Trial Operations to lead Phase 3 clinical trial delivery from start-up to... ...yet hands-on role partners with Clinical Development, Regulatory Affairs, CMC and external vendors to ensure high-quality...SeniorRegulatory
$106k - $130k
...Join to apply for the Regulatory Affairs Senior Associate role at... ...coordinate regulatory submissions, support global regulatory... ...activities for the lead clinical stage asset,... ...information in the RIM system. Support regulatory... ...regulatory standard operating procedures (SOPs)....SeniorRegulatoryFull timeWork at office- ...Pharmaceuticals is seeking an Associate Director, Marketing Operations to lead the orchestration of marketing operations across rare disease... ...‑functional collaboration with Commercial, Medical Affairs, Regulatory, Legal and Finance. The successful candidate will champion...SeniorRegulatory
- Sanofi in Cambridge, MA seeks a Senior Statistical Project Leader (Director) to provide statistical leadership across solid tumor... ...studies. You will guide development plans, protocols, and regulatory submissions, while coordinating multiple complex projects and cross-functional...SeniorRegulatory
$80k - $200k
...Senior Consultant - MedTech Regulatory ImplementationVeeva Systems is a mission... ...experienced consultant to lead MedTech Regulatory... ...Management (RIM) implementations at... ...Regulatory Affairs and Operations processes through industry... ...) or global submission planningInterviewing...SeniorRegulatoryWork at officeLocal areaRemote workWork from home- ...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
- Parabilis Medicines is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and execution across the product lifecycle... ...optimized regulatory plans, with emphasis on NDA/BLA submissions and FDA interactions. The position requires 7+ years in pharma...SeniorRegulatory
$80k - $200k
...Senior ConsultantVeeva Systems is a mission... ...implementation. Veeva's RIM suite is the... ...fully integrated regulatory information management... ...management, submission publishing, and archival... ...planning, leading, and motivating the... ...Affairs, Regulatory Operations, or Pharmacovigilance...SeniorRegulatoryWork at officeLocal areaRemote workWork from home- A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...SeniorRegulatory
- ...design, build, implement, and maintain Veeva Vault RIM, driving the transformation with technology at the core. You will lead complex enhancements, collaborate with... ...translate requirements into robust RIM solutions for regulatory compliance and user satisfaction. You will...Regulatory
- ModernaTX, Inc. is seeking a senior Regulatory CMC leader based in Norwood, MA. You will manage a team of CMC experts, oversee agency correspondence... ...product strategy across the portfolio. The role requires leading regulatory activities to produce high-quality CMC sections...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
$210k - $320k
...biotechnology company committed to establishing the leading, fully integrated platform for precision... ...the lifecycle of the product from IND submission through BLA approval. The candidate will... ...suppliers. Work directly with regulatory and key stakeholders on the development...SeniorRegulatoryFull time- ...design, build, and maintain Veeva Vault RIM. The role supports Biogen’s transformation... ...with technology as a core enabler, ensuring regulatory compliance, high performance, and... ...requirements into functional specifications, lead cross-functional teams, and guide integrations...Regulatory
- ...Development Associate Medical Director to serve as the Medical Lead for multiple clinical trials, shaping strategy, design and... ...and ensure scientific integrity across the study and regulatory submissions. The position requires MD/DO or equivalent and extensive clinical...SeniorRegulatory
- ...Senior Vice President, Global Regulatory Affairs About the Company A clinical-stage biotechnology company... ...a hands-on approach, capable of leading the team in interactions with global... ...regulatory documentation and submissions, providing strategic direction for...SeniorRegulatory
- ...compliance. The ideal candidate holds a PhD or DVM with over 12 years of industry experience and possesses in-depth knowledge of GLP and ICH policies. Excellent presentation and writing skills are essential as well as experience in regulatory submissions. #J-18808-LjbffrSeniorRegulatory
- ...Senior Director Of Biostatistics As the Senior... ...Biostatistics, you will lead and develop the statistical... ...objectives and regulatory standards. In this leadership... ..., clinical operations, and other functions to... ...I through regulatory submissions and post-approval activities...SeniorRegulatory
- ...Apex Systems in Cambridge, MA is seeking a Senior Scientist in Toxicology to shape the... ...influencing discovery, development, and regulatory decisions with cross‑functional teams. You... ..., and author nonclinical sections of regulatory submissions. #J-18808-Ljbffr Apex SystemsSeniorRegulatory
$211.66k - $317.48k
...Job Title: Senior Director US Head of Country Operations, Study Start-up & Site Partnerships... ...Site Partnerships will lead the US operating model and... ...complex market, scientific, regulatory, and performance... ...contracting, budgeting, EC submissions, and site selection in partnership...SeniorRegulatoryHourly payTemporary workWork at officeLocal area3 days per week
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