US Lead, Regulatory Strategy & Execution — Rare Disease
Dormont Manufacturing Co
Dormont Manufacturing Co is seeking an Associate Director, Regulatory Affairs US Lead to develop and execute regulatory strategies for innovative products. The position involves oversight of submissions and ongoing engagement with the FDA to ensure compliance and success in regulatory landscapes. The ideal candidate will have strong experience in US drug development, exceptional communication skills, and a proven ability to synthesize complex regulatory data into actionable strategies. #J-18808-Ljbffr Dormont Manufacturing Co
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the US Lead, Regulatory Strategy & Execution — Rare Disease in Gaithersburg, MD vacancy
- AstraZeneca is seeking an Associate Regulatory Affairs Director to lead the US regulatory strategy for projects focusing on patients with rare diseases. You will guide regulatory strategy development, ensure effective team collaboration, and foster relationships with regulatory...Regulatory
- The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation... ...maintenance of regulatory strategies for assigned project(s)/... ...serving patients with rare diseases and unmet medical needs. This...Regulatory
- ...impact at AstraZeneca by leading strategy for our industry-... ...patient outcomes and bring us closer to eradicating cancer. As Executive Director, Oncology Business... ..., and stage‑specific disease strategies to inform... ...Thorough understanding of regulatory and pricing dynamics in...RegulatoryHourly payTemporary work
$276.13k - $414.19k
...Job Title: Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy... ...access? This role leads the strategy for our... ...knowledge of relevant disease areas, evolving scientific... ..., autoimmune, rare diseases, neurology.... ...person working gives us the platform we need...RegulatoryHourly payTemporary workWork at officeWorldwideFlexible hours3 days per week$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell and Gene Therapy... ...immune-mediated and rare diseases—translating... ...global teams, you will lead strategy across key milestones... ...: Drive strategy and execution for Health Authority... ...person working gives us the platform we need...RegulatoryHourly payTemporary workWork at officeLocal areaFlexible hours3 days per week- ...Executive Director, Regulatory Affairs Strategy, Cell & Gene Therapy About the Company Respected biopharmaceutical... ...targeting cancer, immune-mediated, and rare diseases. The successful candidate will be responsible for leading high-impact programs, guiding them through...RegulatoryFlexible hours
$270.22k - $405.33k
...rely on highly skilled Strategy Leads to craft integrated... ...platforms. -- As an Executive Director, Strategy,... ...impact for patients across disease areas and/or platform... ...competitive dynamics, regulatory environments, and... ...-person working gives us the platform we need to...RegulatoryTemporary workWork at officeFlexible hours3 days per week$113.85k - $189.75k
Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature projects for vaccines. You will manage CMC regulatory... ..., technology and talent to get ahead of disease together. Responsibilities Develop and implement...RegulatoryLocal area- ...seeking a Statistical Science Director to lead innovative statistical strategies in clinical development. In this... ...will guide statistical thoughts for regulatory strategies, ensuring high-quality... ...effective communication skills. Join us in Gaithersburg, Maryland, to make a...Regulatory
- ...Based in Gaithersburg (US), you will partner... ...Accountabilities: Vision and Strategy: Define a multi-year... ...engagement quality, execution, and strategic decision... ..., security, and regulatory alignment across markets... ...A minimum of 5 years leading AI/digital transformation...RegulatoryHourly payContract workTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week
$242.55k - $404.25k
...Position Summary This is a rare opportunity to shape the future... ...delivery at scale. As Disease Area Lead covering Hepatology, Renal and... ...the GSK portfolio - driving strategy, people and performance from... ...portfolio from design through regulatory submission/approvals. Define...RegulatoryLocal areaImmediate start$241.61k - $362.42k
Executive Director, Strategy , Oncology R&D Location: Waltham or Gaithersburg Do you... ...demonstrate those skills to help lead the team that shapes our... .... This approach has enabled us to successfully deliver 7 new... ...may include a specific disease area and/or platform technology...Hourly payTemporary workWorldwide$218.06k - $327.09k
Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy Introduction... ...for patients? This role leads high-impact programs across... ...cancer, immune-mediated and rare diseases, guiding them from current... .... You will report to the Executive Director, Cell and Gene...RegulatoryHourly payTemporary workFlexible hours$130k - $185k
...Area Chief of Staff is to lead, develop and manage... ...a proactive retention strategy, and creating a culture... ...practice manager to develop, execute, and revise plans which... ..., state and federal regulatory requirements including... ...and diversity enables us to live our Purpose: A...RegulatoryFull timeTemporary workPart timeLocal areaFlexible hoursShift workBanfield
Gaithersburg, MD1 day ago$211.58k - $317.37k
...millions of people, where the burden of disease is greatest. During the COVID-19... ...Affairs Director(SRAD)leads the global regulatory strategy for complex products. They aim to secure... ...Global Regulatory Strategyand ensure execution on strategy. Deliver all regulatory...RegulatoryHourly payTemporary work3 days per weekAstraZeneca
Gaithersburg, MD22 hours ago- ...the Oncology Business Unit (OBU) Strategy in Gaithersburg, Maryland. This role involves leading strategic data collection and... ...the oncology pipeline, as well as executing market assessments and revenue forecasts... ...work environment. Join us to make an impact! #J-18808-Ljbffr...
- About Us Capital Bank N.A. is headquartered in Maryland and has been serving our communities... ...American Banker. Position Purpose The Lead Executive Assistant will support the CEO and CFO.... ...of other federal and state regulatory agencies. Compensation Base salary range...RegulatoryHourly payWork experience placementWork at office
$216k - $324k
...deliver a successful strategy aligned to... ...Seaport Boulevard, MA, US or Gaithersburg, US... ...process. As the lead ambassador for the... ...responsible for: Ensuring disease strategy is... ...and efficacy for regulatory approval plus value... ...including work with executive leadership....RegulatoryFull timeTemporary workWork at officeFlexible hours3 days per week$221.56k - $332.35k
...AI Enterprise Partner Lead Introduction to role Evinova... ...this role acts as the executive bridge between Evinova... ...are realised through strategy, adoption, roadmap alignment... ...quality and strengthen regulatory readiness. Act as the... ...-person working gives us the platform we need to...RegulatoryContract workTemporary workWork at officeFlexible hours3 days per week- ...Project Leader US Remote Emmes Group... ...built industry leading capabilities in... ...and infectious diseases, ophthalmology, rare diseases, and neuroscience... ...Innovation, Regulatory Affairs, and... ...to influence and executes project... ...of operational strategy, budget, and proposal...RegulatoryContract workCasual workLocal areaRemote workWork from homeFlexible hours
- ...Global Executive Director, Regulatory Affairs Precigen has developed novel manufacturing... ...of IND/IMPD, BLA and ex-US activities for the CAR-T... ...regulatory leadership and strategy on cross functional sub teams... ...Responsibilities: Lead cross-functional teams responsible...Regulatory
Precigen
Germantown, MD2 days ago - Women In Bio is seeking a professional to lead CMC regulatory strategy for vaccines in Rockville, Maryland. This role requires deep knowledge of FDA regulations, development processes, and collaborative skills with cross-functional teams. The ideal candidate has at least...Regulatory
- A clinical research organization is seeking an Ophthalmology Strategy and Medical Monitor. This role involves strategic medical leadership... ...clinical documents, interfacing with experts, and supporting regulatory processes. Competitive benefits include flexible time off and...RegulatoryRemote workFlexible hours
EMMES Corporation
Rockville, MD3 days ago $225k - $335k
...new medicines driving us forward across different... ...commercial scale, the execution layer of our supply chain... ...Operations, you will lead the function that translates... ..., Free Trade Zone strategy and operations, biological... ..., Commercial, IT, Regulatory, Supply Chain functions...RegulatoryShift work$288.06k
...focused on Kidney Disease and related conditions... ...development and regulatory colleagues who... ...for managing and leading to early phase I-II... ...that are framing our strategies and development... ...Experience designing, executing, monitoring,... ...person working gives us the platform we need...RegulatoryFull timeTemporary workWork at officeFlexible hours3 days per week$198.9k - $318.3k
...scientific communications strategy for one or more... ..., indications, or disease areas across the product... ..., Commercial, HEOR, Regulatory, and Regional/Local... ...Strategy Lead the development and execution of the integrated scientific... ...is filled in the US, the Expected Pay...RegulatoryLocal areaShift work$245k - $392k
...The Department Lead Scientific Communications... ...shaping global publication strategies, and supporting product... ...Clinical, Medical Affairs, Regulatory, Commercial) to ensure... ...planning and execution across Phase I–III clinical... ...position is filled in the US, the Expected Pay Range...RegulatoryFreelanceWorldwide- ...trajectory of autoimmune diseases. Enabling... ...effective. Each of us at Aurinia own Quality... ...quality and regulatory compliance are essential... .... Skills Our strategy leverages the skills... ..., maintain and execute real‑time business... ...rheumatology and/or rare disease experience...Regulatory
- Overview Ophthalmology Strategy and Medical Monitor US Remote Emmes Group... ...has built industry leading capabilities in cell and... ...and infectious diseases, ophthalmology, rare diseases, and neuroscience... ...feasibility assessment, regulatory and medical strategy, and...RegulatoryContract workWork experience placementCasual workLocal areaRemote workWork from homeFlexible hours
The Emmes Company, LLC
Rockville, MD3 days ago - ...trajectory of autoimmune diseases and enable... ...effective. Each of us at Aurinia owns Quality... ...quality and regulatory compliance are essential... ..., maintain and execute real time business... ...and future strategies to ensure sales success... ...Rheumatology, and/or rare disease or...RegulatoryWork at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to US Lead, Regulatory Strategy & Execution — Rare Disease. Be the first to apply!
