Head of Regulatory Affairs - US Strategy & Submissions
Merck & Co.
Merck & Co. is seeking a Head of Regulatory Affairs in Plainsboro Township, NJ. This role involves defining and leading regulatory strategy for product submissions and approvals, and engaging with the U.S. FDA to ensure compliance. Candidates must have a doctorate or advanced degree, a minimum of 15 years of pharmaceutical experience, and strong leadership skills. The position also includes mentoring team members and fostering relationships with regulatory stakeholders. Competitive compensation and extensive benefits are offered. #J-18808-Ljbffr Merck & Co.
- ...Description Our Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and... ...authorization). Author and / or review regulatory documents for submission to US and/or Rest of World regulatory agencies in support of...Suggested
$187.34k - $227.01k
...Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are... ...-with-us . Creative Director - Design Strategy & Brand Stewardship Overview:... ...governance across Corporate Communications, Affairs and the broader organization. Sitting within...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$120.3k - $222.6k
...you ready to maximize your potential with us? The Position The position is... ...alternative model contracting decisions and GTN strategy. Provides support to GTN forecasters on scenario... ...rebates, etc) Monitor industry trends, regulatory developments, patient and payer behaviors...SuggestedContract workLocal areaFlexible hours$122k - $212.75k
...health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated,... ...is currently seeking a Senior Manager, Procurement Network Strategy to be based in Raritan, NJ with consideration for New Brunswick,...SuggestedFull timeContract workLocal areaImmediate start$173.35k - $210.06k
...Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at... ...Summary The Associate Director of Site Contracting Governance & Strategy provides strategic leadership for the regional governance...SuggestedHourly payFull timeContract workTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...courage and passion to drive life-changing impact to ZS. ZS's Data Strategy and Data Office has 2 pillars: First, advising clients on all... ...the team and make it a long term career. Please describe for us why you are interested in this role specifically and why you...ApprenticeshipWork at officeLocal areaWork from homeWorldwideFlexible hours
$107.63k - $130.42k
...Working with Us Challenging. Meaningful. Life... ...audit readiness, global regulatory inspections, and... ...reports, and regulatory submissions, adhere to GLP standards... ...Development, Regulatory Affairs, and Lab Quality... ...enterprise risk mitigation strategies, and risk‑based...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$150.03k - $224.25k
...support in developing global regulatory strategy, planning and execution of... ...marketed prescription drug submissions and manages lifecycle activities... ...' experience in regulatory affairs or related areas (e.g.,... ...Request (****@*****.***-us.com) . Statement...Temporary workWork at officeLocal areaFlexible hours$360k - $400k
Rocket Pharmaceuticals is seeking a Senior Vice President (SVP) of Regulatory Affairs to drive regulatory strategies for innovative gene therapies. This key leadership role involves overseeing regulatory interactions with global health authorities and guiding regulatory...$200.98k - $243.54k
...Working with Us Challenging. Meaningful. Life-changing. Those... ...Summary: The Director, CDA Strategy is a leadership role with... ...automation. This role reports to the Head of Clinical Data Acquisition... ...of industry standards and regulatory requirements and include optimal...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$251.08k - $304.25k
...Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are... ...Executive Director of US Market Access Strategy will lead the integrated market access strategy... .../ payer landscape with its unique regulatory environment (e.g., 340B, IRA). Knowledge...Hourly payPermanent employmentFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$163.21k - $197.77k
Working with Us Challenging. Meaningful. Life-changing. Those... ...-with-us. R&D Quality, Audit Strategy Operationalize and execute the... ...aligned with ICH E6(R3), regulatory expectations, and company objectives... ...quality input to product submission activities as required Business...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$152k - $228.3k
...foresight. We develop an end-to-end approach to strategy, focusing on every touchpoint that... ...and learn" mindset and approach enables us to iterate rapidly and refine our strategies... ...across the team. Privacy-by-Design & Regulatory Compliance: Partner with Legal, Privacy,...Local areaFlexible hoursNight shift$152k - $228.3k
...foresight. We develop an end-to-end approach to strategy, focusing on every touchpoint that... ...and learn" mindset and approach enables us to iterate rapidly and refine our strategies... ...a competitive edge. Privacy‑by‑Design & Regulatory Compliance: Partner proactively with...Work at officeLocal areaFlexible hoursNight shift$156.66k - $189.83k
...Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are... ...the Senior Director of Creative & Brand Strategy, the Associate Director of Graphic Design... ...tools across Corporate Communications and Affairs that democratize design, elevating the...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...Changing lives. Building Careers. Joining us is a chance for you to do important work... ...This role leads global HS classification strategy, origin analysis, and tariff impact... ...Information (BTI) and US binding ruling submissions where appropriate. Conduct classification...
- ...with AI. What You’ll Do The Director/Sr. Director of Pricing Strategy for the AI Platform leads monetization for Teradata’s AI/ML, LLM... ..., bringing their unique perspectives and experiences to help us innovate and grow. If you require accommodations during the interview...Permanent employmentFlexible hours
$240.94k - $291.96k
...Working with Us Challenging. Meaningful. Life... ...-us . Director, US Regulatory Lead, GRS Position... ...will oversee regulatory strategy and execution for... ...including upcoming NDA submission. The incumbent may also... ...experience in regulatory affairs (e.g. 4-7 years),...Hourly payPermanent employmentFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...business value with AI. What you will do: As Director of Product Strategy and Partner Ecosystem, you will sit at the intersection of... ..., bringing their unique perspectives and experiences to help us innovate and grow. If you require accommodations during the interview...Permanent employmentContract workFlexible hours
$126.5k - $208.7k
...property casualty insurers in the industry for over 170 years. Join us to discover a culture that is rooted in innovation and thrives... ...What Is the Opportunity? The Senior Director, BI Operations Strategy & Delivery - Tech Currency role is responsible for translating enterprise...Work experience placementLocal area$132.48k - $198.72k
...Senior Manager, Medical, Regulatory and Legal (MeRL) Operations At... ...would love to have you join us! This is more than a process... ...Ensure timely and compliant submission, routing, review, and approval... ...across Commercial, Medical Affairs, Regulatory, Legal, and external...Full timeWork at officeRemote work$152.07k - $202.76k
...opportunity to make a lasting impact. We’re looking for top-tier talent ready to take on the challenge. Join us in building the future. The Role The Director of Strategy & Research is a critical role in the transformation and growth story of Lumen. This role leads the...Full timeTemporary workRemote work$200k - $300k
...company's success. The Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI... ...Own/drive the preparation, submission, management and maintenance of... ...comprehensive understanding of US FDA, ICH and international pharmaceutical...$220.6k - $275.7k
...The Senior Director, Regulatory Operations provides strategic... ...overseeing electronic submissions, regulatory... ...the Global Regulatory Affairs Leadership Team and plays... ...organizational design, talent strategy, and performance... ...00 USD What we offer US-based Employees: Competitive...Full timeWork at officeLocal areaRemote workWorldwideNight shift3 days per week- ...New Brunswick, NJ. This role will lead the strategy and operations for digital communications... ...Medicine Communications & Public Affairs. The ideal candidate will have over 12 years... ...degree in a relevant field is mandatory. Join us to impact health for humanity and be part...
$122k - $212.75k
...healthcare innovation empowers us to build a world where... ...recruiting for a(n) Sr. Manager, Regulatory Affairs. Johnson & Johnson announced... ...the technology product strategy and delivery for Regulatory... ...solutions that enable faster submissions, stronger compliance, and improved...Contract workLocal areaImmediate start$200k - $245k
...is a leading privately‑owned US biopharmaceutical company... ...offices for an experienced Regulatory Affairs Director to support a 505(b)... ...responsibility for day‑to‑day NDA submission management and delivery. You... ...seamlessly shift between strategy input and tactical execution...Full timeWork at officeShift work- ...client is seeking a Director Regulatory Affairs Chemistry Manufacturing &... ...and execution of regulatory strategy and the design of CMC components... ...as a back up to the Head of Regulatory CMC. REQUIREMENTS... ...experience with authoring, submission, and approval process of a major...Work at office
- ...discover new, on trend solutions. As a Regulatory Manager , you will oversee day-to-day... ..., COO, Prop 65, flavor labeling, TTB submissions, and more). Support global market-entry... ...sponsorship for this role. More about us: Vibrant Ingredients, headquartered...
- ...Job Title: Director of Pricing Strategy and Transformation About Trellix ? Trellix is a global company redefining the future of cybersecurity. The company's comprehensive, open, and native cybersecurity platform helps organizations confronted by today's most...Flexible hours
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