Regulatory Strategy Director - Biologics & Rare Diseases
Scholar Rock
Scholar Rock is seeking an Associate Director, Regulatory Strategy, to lead development and execution of regulatory plans for clinical and pipeline programs. You will represent regulatory affairs in program teams, highlighting risks and opportunities to inform strategy and plan. You will lead interactions with regulatory authorities, directing preparation and submission of regulatory documents and communications to agencies, ensuring timely and compliant outcomes across programs. #J-18808-Ljbffr
- ...Alexion, part of AstraZeneca’s Rare Disease unit in Boston, seeks a Director of Regulatory Affairs US to drive regulatory strategies for complex products and lead US submissions. You will coordinate with FDA and Global Regulatory teams to align on strategy, timelines,...Suggested
- ...challenge the status quo for the better. Chiesi Global Rare DiseasesChiesi Global Rare Diseases is a Chiesi Group’s business unit established in February... ...is capable of developing a coherent data collection strategy for providing business insights supporting successful product...SuggestedHourly payLocal areaRemote workRelocation packageFlexible hours
- ...Alexion Pharmaceuticals, Inc. is seeking a Director, Strategic Pricing Management based in Boston Seaport to shape US pricing for pipeline and in-line products within the rare disease portfolio. You will report to the Executive Director, US Strategic Contracting & Pricing...Suggested
- ...Biogen seeks a Director of Rare Disease Market Access Strategy to lead the development and execution of the Market Access & Reimbursement (MA&R) strategy for SMA and ALS in the US. You will build payer messaging, pricing, contracting, and coordinate across MA&R functions...Suggested
$217.5k - $300k
...Strategic Initiatives is a member of the Rare Disease Business Unit (RDBU) Leadership Team... ...accountable for translating franchise strategy into an integrated operating plan, establishing... ...strict compliance to all appropriate regulatory guidelines to successfully design and...SuggestedTemporary workWork at officeFlexible hours- ...quo for the better. Chiesi Global Rare DiseasesChiesi Global Rare Diseases is a Chiesi Group’s business unit... ...developing and implementing the EAP strategy for the Americas in alignment with... ...stakeholders, including Regulatory, Pharmacovigilance, Quality, Supply...Hourly payLocal areaRemote workRelocation packageFlexible hours
- ...Chiesi Global Rare Diseases in Boston, MA seeks a Senior Manager, HIDO Global Strategic Insights to lead market trends analysis and strategic... ...in scope, with responsibilities spanning data collection strategy across primary, secondary, and competitive intelligence....
- ...Access Programs, Americas, Global Rare DiseasesBased in Parma, Italy... ...areas. Chiesi Global Rare Diseases is a Chiesi Group's business... ...and implementing the EAP strategy for the Americas in alignment... ...functional stakeholders, including Regulatory, Pharmacovigilance, Quality,...
$196.7k - $353.4k
The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters... ...in gaining market approval for messenger RNA infectious disease vaccines as unprecedented new drug modality globally. The...Permanent employmentFull timeWork at officeWork from home- ...Reporting to : VP, Regulatory Affairs & Quality... ...the body's own biology and stop bleeds before... ...The role As Director, Regulatory... ...global regulatory strategy for Hemab's development programs in rare bleeding disorders... ...have Rare disease, hematology or coagulation...Remote work
$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible... ...global CMC regulatory strategies for development-stage... ...scientific foundation in biologics and/or complex modalities... ...the lives of people with rare and common diseases. Built on Nobel Prize-...Full timeTemporary workWork at officeLocal areaFlexible hours- ...spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a... ...As a global leader in myostatin biology, a field focused on proteins that regulate... ...: The Vice President, Head of Regulatory Strategy, reporting to the SVP, Global Head...Work at officeLocal areaShift work
$217.5k - $300k
...Ipsen seeks a Head of Commercial Operations & Strategic Initiatives for its Rare Disease Business Unit in Cambridge. This senior leadership role translates franchise strategy into integrated operating plans, manages RDBU governance and business performance, and leads...$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical... ...programs (1) in emerging disease areas, (2) for additional development... ...Education & Experience:Bachelor's degree in Biology, Chemistry, or other related...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week- ...Korsana Biosciences, Inc. is seeking a Senior Director of Biologics Analytical Development and Quality Control to lead analytical development... ...biotech environment. The position emphasizes CMC strategy, regulatory submissions (IND/IMPD/CTA), and ensuring data quality for...
- ...AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch, and lifecycle for... ...authorities and collaborate with global teams to shape regulatory strategies and compliance. With 6+ years in regulatory affairs, you will...Local area
- ...ARTBIO, a pioneering biotech company, seeks a Senior Director of Regulatory Affairs to lead regulatory interactions for clinical-stage radiopharmaceutical programs. You will coordinate medical writing, ensure compliant submissions, and partner with Clinical, Medical,...
- ...Olema Oncology seeks a Director, Global Regulatory Strategy Lead to guide innovative regulatory strategies across its oncology portfolio. Based in Boston or San Francisco, you will lead cross-functional teams, oversee submissions (INDs, NDA/BLA), and partner with global...
- ...AstraZeneca plc in Cambridge, MA, invites you to shape regulatory strategy across development, commercialization and life cycle management. You will lead regulatory planning, coordinate with product teams, and influence authorities to secure timely approvals while ensuring...Local area
$268.2k - $402.2k
## Executive Director, Regulatory Strategy, Cell & Gene TherapyApplylocations: Boston, MA: Washington, DCtime... ...Experience:*** Bachelor's degree in Biology, Chemistry, or other related... ...transformative medicines for people with serious diseases. The company has approved medicines...Summer workLocal areaRemote workFlexible hours2 days per week$152.6k - $283.4k
...(FSHD). As the Associate Director, Patient Marketing Strategy, you will develop and execute... ...initiatives that support disease awareness, engagement, and... ..., Communications, Legal, Regulatory, Compliance, Customer Experience... ...marketing with either rare disease, specialty,...Local areaRemote workRelocationShift work- ...not offered with this role. Rare disease biopharma at Alexion, a... ...science, translating complex biology into transformative medicines... ...is what you will do: The Director, Strategic Pricing Management will shape US pricing strategies for pipeline and in-line products...Hourly payPrice workTemporary workWork at officeRemote workFlexible hoursNight shift3 days per week
- AbbVie in Cambridge, MA, seeks a Director Regulatory Affairs Global Regulatory Lead (GRL II) for Neuroscience. You will develop global regulatory strategies, lead the GRPT, oversee dossier development, and ensure compliant submissions across US, EU, and other regions. You...
- Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner with global clinical development teams to navigate milestones, submissions, and lifecycle activities. The...
- Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning preclinical and early clinical programs. You will serve as the global regulatory lead and primary contact with FDA and other authorities, guiding...
$116k - $174k
Job DescriptionThe Manager, Disease Strategy Finance is a key member of Vertex's Disease Strategy Finance Team, providing financial and strategic... ...(“DSTs”) on key decisions. This role will work closely with Directors on the DST Finance team to conduct financial modeling,...Full timeContract workSummer workRemote workFlexible hours2 days per week$180.7k - $271.1k
...medicines for people with serious diseases. Our finance function is... ...the biotechnology industry.The Director of FP&A, DST Finance is a key... ...for assigned Disease Strategy Teams (“DSTs”) to help define... ...development, manufacturing, regulatory, and commercialization.Expert...Full timeSummer workRemote workFlexible hours2 days per week- ...SERB Pharmaceuticals in the US seeks a Director, Medical Strategy – Rare Emergency Medicine to lead the integrated medical strategy across the portfolio, partnering with Clinical Development, Regulatory, Market Access and Commercial teams to drive launches and lifecycle...
$215k - $235k
...medicines addressing serious diseases for which there are... ...!About the Role:The Director of Regulatory Affairs is... ...for leading regulatory strategy and execution for Abror... ...such as Orphan Drug, Rare Pediatric Disease, Fast... ...preferredExperience with biologics, gene therapy, or...$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function, driving the regulatory strategy for biologics and ATMPs in Biogen’s portfolio. Your role encompasses global, regional...Full timeTemporary workLocal area
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