Regulatory Submissions Lead — Dossier Planning & Ops
Exelixis
Exelixis seeks an Associate Regulatory Operations Director to oversee submission activity for our global portfolio, ensuring staffing and timely filings. The role requires deep knowledge of regulatory submission requirements and collaboration across Regulatory Affairs and cross-functional teams to achieve filing objectives. The candidate will guide Veeva RIM practices, develop best practices for submission timelines, mentor staff, interpret guidelines, and drive process improvements to enhance #J-18808-Ljbffr Exelixis
- Exelixis is seeking a Senior Regulatory Affairs role in California to develop and implement... ...timely preparation of organized submissions and translate regulatory requirements into practical plans. You will interact with authorities, lead cross-functional teams, review trial...Regulatory
$157.5k - $222.5k
...Alameda, California, is looking for an Associate Regulatory Operations Director to oversee regulatory submission activities and ensure effective collaboration within... ...to $222,500, comprehensive benefits like a 401(k) plan, medical coverage, and ample vacation days. #J-18...Regulatory- Exelixis Inc in Alameda, CA is seeking a Regulatory Affairs leader to develop and implement global regulatory strategies... ...preparation of organized, scientifically valid submissions and communicate regulatory plans to stakeholders to mitigate risk. The role requires a...Regulatory
$157.5k - $222.5k
SUMMARY/JOB PURPOSE: The Associate Regulatory Operations Director is responsible for overseeing submission activity for the company’s... ...RESPONSIBILITIES:Oversees the planning of all regulatory submissions... ...stakeholders and management. Leads a cross-functional team within...RegulatoryFull timeWork at officeLocal areaFlexible hours$157.5k - $222.5k
Overview The Associate Regulatory Operations Director is responsible for overseeing submission activity for the company’s submission... ...Responsibilities Oversee the planning of all regulatory submissions... ...stakeholders and management. Lead a cross‑functional team within...RegulatoryLocal areaFlexible hours$107.44k - $232.8k
...Patient Access & Experience Applications Lead is responsible for the technical design,... ...its affiliates are part of Delta Dental Plans Association (DDPA), a not-for-profit national... ..., and aligned with operational, regulatory, and enterprise standards.Act as the senior...RegulatoryLocal areaVisa sponsorshipWork visa$153k - $210k
...IT /External /On-siteAs a BI Integration Lead at Penumbra, you will play a critical... ...practices• Support the integration roadmap planning, estimation, and technical decision-... ...future-state architectures.• Knowledge of regulatory and audit requirements (SOX, SOC- as applicable...RegulatoryTemporary workWork at officeLocal area$120k - $160k
...is looking for a qualified Transmission Planning Engineer for one of its clients. WHAT THE... ...organization is the functional lead for the procurement of materials and services... ...strategies that align with business objectives, regulatory requirements, and industry best...RegulatoryFull timeContract workWork experience placementWork at office- ...Market Access Strategy & Pull Through to lead payer and access marketing initiatives... ...organization and partner with HEOR, medical, regulatory, and other teams to secure and optimize... ...background in payer dynamics, strategic planning, and cross-functional collaboration,...Regulatory
- Penumbra is seeking a Procurement Process Excellence Lead to optimize procurement practices, develop strategies, and drive measurable... ..., implement ERP/P2P solutions, and ensure adherence to QMS and regulatory standards while collaborating with cross-functional teams. This...Regulatory
$100.03 - $132.51 per hour
...You Will Do The essential functions of a Lead Advanced Practice Professional fall in... ...Administration; and Internal/External Legal/Regulatory Issues. The Lead APP must supervise a... ...: Review and participate in financial planning and issues for the service. Participate...RegulatoryHourly payFull time- ...Management Group, is seeking a Sous Chef to lead culinary operations for a senior living... ...in California. You will oversee meal planning, preparation, and service, ensuring high... ...inventory, controlling costs, and ensuring regulatory compliance. Health benefits, retirement...Regulatory
- ...Laboratories in Alameda, CA seeks a Sr. Quality Specialist to lead complex quality and regulatory initiatives that impact patient safety and business... ...regulatory reporting decisions, and the preparation of submissions such as MDRs, MedWatch, and Vigilance. It requires...Regulatory
- ...AECOM is actively seeking an experienced Lead Project Geologist / Assistant Project... ...investigation and remediation projects from planning through execution. You will provide... ...review technical reports, work plans, and regulatory deliverables. Support Project Managers...RegulatoryFull timeFor subcontractorWork at officeLocal areaImmediate startWorldwideFlexible hoursNight shift
- ...gene therapy CRDMO programs within an IPD framework, supporting the full product development lifecycle from design to regulatory submission. You will lead cross-functional teams, co-own outcomes with sponsors and partners, and ensure transparency, risk surfacing, and...Regulatory
$268.5k - $380k
...PURPOSE:The Executive Director, Regulatory Affairs has oversight for all... ...into practical, workable plans. Develops and implements strategies... ...and scientifically valid submissions. Provides expertise in... ...functions. Has extensive experience leading multiple projects involving...RegulatoryFull timeContract workWork at officeLocal areaFlexible hours- ...Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs... ...will be responsible for leading the preparation and maintenance of various regulatory submissions, serving as the primary liaison... ...overseeing clinical trial planning, execution, and ensuring compliance...Regulatory
- ManpowerGroup Global, Inc. seeks a Regulatory Affairs Associate in Alameda, CA, to support the Regulatory Affairs team by ensuring compliance and collaborating on regulatory submissions. The ideal candidate holds a Bachelor's degree and has at least 2 years in regulated...Regulatory
- ...Auto Care is seeking an energetic Automotive General Manager to lead operations, drive sales, and ensure top-tier guest satisfaction... ...feedback, stay current with industry trends, and ensure regulatory compliance in a fast-paced, high-volume shop. #J-18808-Ljbffr...Regulatory
- ...research proposals preparation and submission, as applicable. Oversees the... ...study documentation sent to regulatory bodies (e.g., IRB) for pre-... ...of clinical trials while planning the effective, long-term design... ...guidelines and expectations. Leads, adapts, implements, and stays...RegulatoryContract workFor contractorsFor subcontractorLocal area
- Exelixis, Inc. is seeking an Associate Regulatory Operations Director in Alameda, CA. This role is responsible for overseeing submission activities and managing the submission forecast. The ideal candidate will have substantial experience in regulatory operations and will...Regulatory
- ...base, allow for flexibility in project planning and execution phases, and provide budgeting... ...the maintenance of the Global Regulatory Affairs filing system and the Registration... ...required certificates and tracking of submission under Health Authority review. Continued...RegulatoryWork at officeImmediate start
$90k - $180k
...AlamedaJob Type: Full timeCategory: Regulatory AffairsIndustry:... ...spectrum of healthcare, with leading businesses and products in diagnostics... ...in our Health Investment Plan (HIP) PPO medical plan in the... ...of documentation to support submission activities to meet program objectives...Regulatory$100k - $200k
...AlamedaJob Type: Full timeCategory: Regulatory AffairsIndustry:... ...spectrum of healthcare, with leading businesses and products in diagnostics... ...in our Health Investment Plan (HIP) PPO medical plan in the... ...for leading global regulatory submissions, which include but not limited...Regulatory$115k - $130k
...Job Description: Director of Regulatory Affairs and Policy SupplyBank.org... ...infrastructure, and social impact alongside leading experts in engineering, environmental planning, nonprofit operations, workforce... ...funding strategies, and related submissions prepared by third‑party...RegulatoryWork at officeLocal areaRemote work3 days per week$120k - $185k
...enhance business processes and investor relations. This position involves working closely with leadership on fundraising, strategic planning, and operational metrics analytics. The ideal candidate has over 5 years of relevant experience, particularly in biotech or life...Remote job$148.7k - $297.3k
...spectrum of healthcare, with leading businesses and products in diagnostics... ...in our Health Investment Plan (HIP) PPO medical plan in the... ...This Associate Director Regulatory Affairs will work on-site out... ...data to complete a regulatory submission.Write and edit technical...RegulatoryWorldwideShift work- ...spectrum of healthcare, with leading businesses and products in diagnostics... ..., and other applicable regulatory requirements. Participate... ...trial-specific monitoring plans. Assist senior staff in study... ...in preparation of regulatory submissions. May interact with RA/QA...RegulatoryInterim role
- DescriptionJob Summary:Leads a staff of audiologists in providing diagnostic and therapeutic... ...ensure compliance with TPMG and outside regulatory agency standards. Makes recommendations... ...Aid Center initiatives and assists in planning for new equipment, space and facility...RegulatoryLocal area
- ...related legal matters, which may include regulatory and compliance issues; and identifying... ...Practices self-leadership; creates and executes plans to capitalize on strengths and improve... ...by: preparing, drafting, creating, and leading conversations on complex and nuanced...Regulatory
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