Senior Regulatory Strategy Specialist — Submissions & Compliance
Neurocrine Biosciences
Neurocrine Biosciences is seeking an experienced Regulatory Submissions Specialist to coordinate preparation of submissions to regulatory authorities, including INDs and annual reports. You will ensure alignment with FDA, ICH guidelines and internal policies while maintaining logs and timelines for multiple programs. The role requires strong business understanding, excellent communication, and meticulous attention to regulatory detail, with opportunity to influence submission strategies and #J-18808-Ljbffr Neurocrine Biosciences
- Senior Regulatory Affairs Specialist - Medical Devices Clinical San Diego , California... ...and U.S. medical device submissions . This individual will... ...approvals, maintain regulatory compliance for marketed products,... ...of regulatory strategies for new and existing products...SeniorContract work
$120k - $160k
Senior Regulatory Affairs Specialist Location: Remote (U.S. only, excluding Alaska and Hawaii) Job Type: Full... ...AI/ML framework, and drive submissions to completion. You'll lead Fast 510... ...stay on track. Develop regulatory strategies — Conduct pathway assessments (510(...SeniorFull timeRemote workFlexible hours$99k - $129k
## Senior Regulatory Affairs SpecialistApplyremote type: Fully... ...Regulatory Affairs Specialist** with global... ...product registration strategies, help guide project... ...from preparation to submission and through successful... ...maintain regulatory compliance for significant changes...SeniorFull timeWork at officeRemote work- ...Facebook, Instagram, X and YouTube. Job Description The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact,... ...detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances...SeniorTemporary workWork at officeRemote work
$92k - $138k
...team partners across regulatory, quality,... ...functions to maintain compliance throughout the product... ...to be minimal. The Senior Regulatory Affairs Specialist supports regulatory... ...preparing regulatory submissions, maintaining regulatory... ...Provide regulatory strategy and guidance for...SeniorPermanent employmentH1bLocal areaFlexible hours$82k - $131.5k
...Overview Reporting to the Regulatory Affairs Manager, the Senior Regulatory Affairs Specialist independently leads... ...overseeing study start-up, submissions, maintenance, and ongoing compliance with independence and... ...activities and strategies including submissions and...SeniorFull timeInterim roleWork at officeLocal areaRemote work- ...both in and out of the office. We are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy/operations for our Software as a Medical Device... ...across the product lifecycle, including submission support, document management, change assessments...SeniorRemote jobWork at officeLocal areaFlexible hours
- ...Senior Regulatory Affairs Specialist This will person will be a Regulatory liaison between product development and the regulatory agencies. This position will be responsible for regulatory submissions for new ANDAs and any changes being made to existing products. The...Senior
- ...to support executive reporting, strategy and planning for Raymond James’ Compliance department and other internal partners... .... Routinely interacts with senior leaders within Compliance, Risk,... ...Commission (SEC); Financial Industry Regulatory Authority (FINRA); state...Senior
$84.9k - $120.57k
...develop recommendations for the company's physical security regulatory compliance with Federal, State and local jurisdictions. Consult with... ...results that reflect the company's regulatory policies and strategies of physical security mandates, policies and initiatives Advocate...SeniorTemporary workFor contractorsLocal areaFlexible hours- Harba Solutions Inc. is seeking a Regulatory Affairs professional to manage end-to-end eCTD submissions, maintain regulatory documentation, and support FDA activities for marketed pharmaceutical products. You will monitor FDA and international guidelines, draft labeling...
- This is an insurance regulatory reporting role, not a software engineering... ...and accurate manner for submission to state insurance... ...data capture mechanisms and strategies that will maximize usability... ...reach, timing,relevance, and compliance of every consumer engagementLife...SeniorWork at office
- ...experienced in leading the strategy behind how life-... ...highly motivated Global Regulatory Labeling Lead to... ...labeling decisions by senior leadership. Interpret... ...Operational Oversight & Compliance Oversee operational labeling... ...reviews, and U.S. SPL submissions. Maintain labeling...SeniorWork at officeLocal areaRemote workWorldwide
- ...improve process efficiency, and keep the fair lending compliance program aligned with industry and regulatory standards.Leverage AI-enabled tools, generative AI... ..., practices, and procedures to inform analytic strategies; develop quantitative and statistical models;...Senior
- Responsibilities· Represent the Regulatory Reporting team in the New Products Committee,... ...data sources to ensure timely regulatory compliance.· Review Federal Reserve SR letters to... ...understood.· Contribute to the preparation and submission of selected schedules for the Call...SeniorWork at office
$119k - $218.3k
Position Summary Senior Consultant - Risk, Regulatory, & Licensing - Digital Assets Regulatory & Financial... ....Assess and design risk management strategies for new and emerging digital asset... ...with up-to-date perspectives on compliance obligations and industry best...SeniorWork at office- ...Consulting, LLC. is seeking a Talent Management Specialist to independently provide staffing and... ...advise management officials, ensure compliance with OPM rules, and support onboarding,... ...include developing recruitment strategies, evaluating applications, and coordinating...Senior
- Trulioo Information Services Inc. is seeking a Senior Director of Corporate Strategy & Development to shape the company’s strategic direction and align it with functional priorities. You will own evolving strategic blueprint, drive governance, and lead major strategic initiatives...Senior
- Willis Towers Watson is seeking a Health and Benefits Senior Director in Nashville to lead client engagements across health and welfare programs. You will drive strategy, grow relationships with current clients, and participate in prospecting to generate new business while...Senior
- ...complex appellate matters from initial review through final disposition. Responsibilities include drafting briefs and motions, developing appellate strategies, preparing for oral arguments, and ensuring compliance with deadlines in state and federal #J-18808-Ljbffr NACBASenior
- PHM, a leading health media agency, seeks a Director of Strategy to direct integrated media plans across pharma and healthcare brands. You will guide cross-functional teams, oversee multi-channel strategies, and advise clients on performance-driven media decisions. The...Senior
- Capital One is seeking a Senior Director, Product Strategy and Analysis to support the Consumer and Developer Experience leadership. This role partners with senior CDX leaders to shape business strategies for diverse product areas, including AI-driven platforms, and to...Senior
- Energy Transfer Partners, L.P. in Houston seeks an experienced regulatory liaison to act as the company’s representative with outside... ...preparing for audits, training staff, and maintaining SOPs and compliance programs, including odorization and critical infrastructure, with...Senior
- Unilever in Hoboken is seeking a Senior Manager NRM Deso to drive growth through portfolio optimization, pricing, and promotional spend... .... You will partner with Marketing, Sales and Finance to align strategy and execution across the portfolio. You will shape price...Senior
- EAB is hiring a Senior Director, Digital Marketing Strategy, Advancement to drive digital fundraising and engagement for education partners. You will partner with BD teams, shape campaigns, and influence product strategy across higher education advancement. The role requires...Senior
- EY is seeking a Senior Manager for its Life Sciences Regulatory Submissions practice in Hoboken, NJ. This pivotal role involves leading the team and driving growth... ...while establishing EY as a leader in regulatory compliance. The ideal candidate will have extensive...Senior
- ...optimal shelf presence. You will partner with cross-functional teams to execute assortment, pricing, promotions, and private label strategies. The role requires a Bachelor's in Business, Marketing or Supply Chain and at least five years in marketing/category/product...Senior
- ...seeking a Consulting Actuary - ACA Risk Adjustment to lead pricing strategies and actuarial initiatives across business segments, evaluating... ...maintaining high standards of actuarial practice. This is a senior role with opportunities to influence strategy and partner with...Senior
- The Working Families Party in California seeks a Senior Finance Director to set and drive the state's fundraising strategy, manage high-capacity donor relationships, and build the infrastructure to meet multi-cycle goals. You will lead a portfolio of major donors, supervise...Senior
- Twilio is seeking a Senior HRBP Manager, GTM - Strategic Growth, Partners & Sales Enablement. This role operates in a remote-first setup... ...leaders across IR&SG, Partners, and GTM SOE to drive workforce strategies at scale. You will leverage data, AI insights, and...SeniorRemote job
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Strategy Specialist — Submissions & Compliance. Be the first to apply!
- research compliance officer Brooklyn, NY
- trade compliance specialist Brooklyn, NY
- privacy compliance analyst Brooklyn, NY
- senior compliance analyst Brooklyn, NY
- regulatory compliance associate Brooklyn, NY
- regulatory officer Brooklyn, NY
- senior regulatory affairs specialist Brooklyn, NY
- legal compliance officer Brooklyn, NY
- cybersecurity policy and compliance analyst Brooklyn, NY
- healthcare compliance officer Brooklyn, NY

