Average salary: $160,970 /yearly
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$196.7k - $353.4k
...agencies. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly and effectively... ...authorities. Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory...SuggestedPermanent employmentFull timeWork at officeWork from home$116k - $151k
...courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and contributes to the...SuggestedFull timeContract workTemporary workRemote work$177k - $278.08k
...creation of a new TLP, CCDS, USPI and EU SmPC.How you will contribute:Management of Labeling Cross-Functional TeamsLeads Labeling cross-... ...as "remote" in accordance with Takeda's Hybrid and Remote Work policy.#LI-Remote#LI-AA1Takeda Compensation and Benefits SummaryWe understand...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$232k - $348k
...functional teams and GRA leadership. Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics,... .... Remains up to date on changing regulations, and regulatory policy and intelligence including competitive issues that influence regulatory...SuggestedFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week- ...compliance, as well as sophisticated HR issues, including leave management and employee relations. Acting as a bridge between dense... ...strategies, variable hour determinations, and measurement period policies tailored to governmental workforces. HIPAA & Privacy Leadership...SuggestedFull timeRemote work
$196.7k - $353.4k
...dealing with broad range of stakeholders at all levels internal and external to the company Demonstrated competence in employee management and development Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration...SuggestedPermanent employmentFull timeWork at officeWork from home- ...Conducts research related to labeling precedent, regulations, policies, and other topics as necessary to properly advise on potential... ...and be responsible for the strategic development and lifecycle management of labeling for that/those area(s), including TLPs.Knowledge...SuggestedFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week
- ...provisions, including eligibility requirements, vesting schedules, and employer contribution formulas.Oversee retirement plan document management and restatement cycles for 401(k), 403(b), and other qualified retirement plans, ensuring alignment with regulatory requirements...SuggestedWork at officeRemote workFlexible hours
$268.2k - $402.2k
...commercialization of programs within the T1D portfolio. This position will manage a group of global/regional regulatory professionals with... ...and contribute to improving the quality of internal regulatory policies, programs and initiatives.A strong leader who demonstrates...SuggestedFull timeSummer workLocal areaRemote workFlexible hours2 days per week$189k - $246k
...sciences industry. Significant experience leading regulatory strategy for Phase 2 and Phase 3 development programs. Demonstrated success managing interactions with FDA and other major global health authorities. Experience supporting or leading NDA, BLA, MAA, or equivalent...SuggestedTemporary workLocal areaRemote workWeekend workTravere Therapeutics
Des Moines, IA2 days ago- ...Radical Ventures and NVIDIA. Learn more about our vision, team, and backers at About the Role We’re looking for a Policy & Regulatory Affairs Manager to help shape and execute our policy and regulatory strategy at a critical moment of growth. As demand accelerates and...SuggestedWork from homeFlexible hours2 days per week
$152.3k - $206.1k
...growing businesses at Amazon and that growth generates challenges in managing huge volumes of advertising submissions while maintaining a... ...for our advertising partners.As part of Advertising Trust’s Policy & Integrity team, you will have high visibility across Amazon business...SuggestedLocal areaFlexible hours$85k - $90k
...JOB SUMMARY: The Manager of Public Policy is a member of Truth Initiative's Public Policy team and advances the organization's policy priorities by conducting strategic policy research and analysis; monitoring and evaluating legislative, regulatory, and public health...SuggestedFull timeWork experience placementWork at officeLocal areaRemote work$200k - $235k
...studies and marketing approval in US. Serves as primary regulatory contact for alliance product brands, as assigned, including managing cross-functional and multi-leveled governance and alignment meetings. Assesses scientific data for registration purposed against...SuggestedWork at officeRemote workFlexible hoursLundbeck
Deerfield, IL5 days ago$165k - $185k
...candidates within the United States SUMMARY: The Senior Manager, Regulatory Strategy (US RA): supports the creation and... ...current FDA guidance’s, regulations, and precedence. Facilitates policy and development of standard interpretation of US regulations....SuggestedFull timeWork at officeRemote workFlexible hoursLundbeck
Deerfield, IL4 days ago$189k - $246k
...including the FDA and EMA. The ideal candidate will have 10+ years in regulatory affairs, strong leadership skills, and experience in managing major regulatory submissions. Competitive compensation includes a base salary range of $189,000 to $246,000. #J-18808-Ljbffr...Remote job$200k - $250k
A leading regulatory consulting firm is seeking a Senior Director for Regulatory Strategy Consulting to architect global regulatory strategies and lead cross-functional teams. The role demands 15 years of regulatory affairs experience and a strong skill set in business ...Remote jobFull time- ...are compliant, consistently implemented, and aligned with state accountability standards across campuses. You will oversee grading policies, SIS configurations, and reporting with a focus on fidelity, audits, and continuous improvement while partnering with academic...
- ...excellence. Qualified candidates will have over 10 years of experience, a strong understanding of the regulatory landscape, and the ability to manage complex issues. Comprehensive benefits and competitive compensation are included. #J-18808-Ljbffr Travere TherapeuticsRemote job
- A biotechnology company focused on MASH and liver fibrosis is seeking a (Senior) Director, Regulatory Affairs. In this remote role, you will lead U.S. regulatory strategy, particularly for FDA engagement and regulatory submission mechanics. The ideal candidate should have...Remote job
- Travere Therapeutics is seeking a Director, Regulatory Affairs Strategy to develop and execute global regulatory strategies for Phase 2 and Phase 3 programs. You will work closely with teams to ensure compliance and strategic alignment with regulatory bodies. The ideal ...Remote job
- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute regulatory strategies for clinical programs. This role requires 10+ years of experience in regulatory affairs and a strong understanding of global drug development. The successful...Remote job
- ...authorities like the FDA. The ideal candidate will have 10+ years of experience in regulatory affairs, strong communication skills, and the ability to manage complex regulatory issues. Travere offers competitive pay and extensive benefits. #J-18808-Ljbffr Travere TherapeuticsRemote job
- Veristat, Inc. seeks a Senior Business Development Director for Regulatory and Medical Writing to lead growth initiatives across pharmaceutical and biotech clients. This fully remote role requires experience in the CRO industry, with responsibilities including developing...Remote work
- Stryker Corporation is looking for a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts. This fully remote position involves coordination with FDA and overseeing regulatory submissions in the pharma/biotech field. Candidates should have extensive...Remote job
$189k - $246k
Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute comprehensive regulatory strategies supporting clinical development and commercialization of investigational products. The role involves collaborating with cross-functional ...Remote job- ...or Director to lead Global Regulatory Affairs on an initial contract. You will drive regulatory strategy, lead FDA interactions and manage submissions for multiple development programs, with potential conversion to permanent roles. Remote work is supported during the...Remote jobPermanent employmentContract work
$189k - $246k
...global regulatory strategies for Phase 2 and Phase 3 drug development programs. As the regulatory lead, you will ensure compliance, manage interactions with global health authorities, and guide cross-functional teams towards achieving corporate objectives. Candidates...Remote job$210k - $235k
Vor Bio is looking for a Director of Regulatory Strategy in Boston, MA. This role involves global leadership in regulatory strategy for developmental programs in immunology. The Director will work closely with cross-functional teams to ensure compliance and effectively ...Remote jobFlexible hours$75k - $115k
...helps brands achieve compliance outcomes through advanced data management and regulatory expertise. Headquartered in New York. Learn more... ...education and enablement content. Write regulatory briefs, policy gap assessments, regulatory updates, blog posts, FAQs, explainers...Live inWork at officeRemote workWorldwideFlexible hoursShift work3 days per week
