Global Regulatory Submissions Lead
AstraZeneca GmbH
AstraZeneca GmbH is seeking a Regulatory Affairs Manager to lead regulatory submissions that accelerate access to life-changing medicines. You will plan, coordinate, and deliver high-quality applications, working with cross-functional teams to influence submission strategies. Essential qualifications include a Bachelor’s degree and 3+ years of regulatory experience in the biopharmaceutical industry. The position offers a competitive salary range, bonuses, and comprehensive benefits. #J-18808-Ljbffr AstraZeneca GmbH
$200k - $220k
Precigen is seeking an Associate Director/Senior Manager, Regulatory Affairs in Germantown, MD. The role involves managing regulatory affairs... ...and commercial products and ensuring compliance with global regulatory requirements. The ideal candidate should possess a bachelor...RegulatoryFull time- ...Manufacturing Co in Gaithersburg, Maryland is seeking a Global Clinical Program Lead for late development in oncology. This role entails overseeing... ...cancer, while collaborating with diverse teams and regulatory bodies. The ideal candidate will have an M.D. or equivalent...Regulatory
$183.41k
...oversight on donor-funded projects related to Pharmacovigilance and Regulatory Services Strengthening. Candidates need a Bachelor's degree and... ...of experience in regulatory affairs. The position supports global health initiatives, requires engagement with stakeholders, and...RegulatoryRemote work- The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for... ...delivering according to regional and global Business Objectives. They will... ...Lead on assigned programs; act as submission sub‑team lead for US submissions and...Regulatory
$216k - $324k
...join Respiratory & Immunology (R&I) as a Global Product Leader (GPL) for an asset in Respiratory... ...perspectives into the process. As the lead ambassador for the product, both... ...balanced focus on safety and efficacy for regulatory approval plus value for market access. Delivering...RegulatoryFull timeTemporary workWork at officeFlexible hours3 days per week- 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...Regulatory
$221.56k - $332.35k
...Digital and AI Enterprise Partner Lead Introduction to role Evinova is a global AI-powered health tech business,... ...management and study build through to submission. Deployed across more than 54... ...data quality and strengthen regulatory readiness. Act as the executive...RegulatoryContract workTemporary workWork at officeFlexible hours3 days per week$178.53k - $267.8k
...AstraZeneca GmbH is seeking a Regulatory Affairs Director in Gaithersburg, MD. In this role, you will provide... ...regulatory leadership for oncology products, leading cross-functional teams and managing regulatory submissions. With a strong focus on collaboration, you'll influence...Regulatory- AstraZeneca GmbH is seeking a regulatory leader in Gaithersburg, MD, to oversee the global CMC strategy for cell and gene therapies. You will ensure the delivery of high-quality submissions and navigate complex health authority interactions. The ideal candidate will possess...Regulatory
$113.85k - $189.75k
Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature projects... ...with FDA expectations and global standards. Prepare and review... ...., with a focus on IND and BLA submissions to the FDA. Experience as a liaison...RegulatoryLocal area$217k - $325.49k
...senior leader to define and execute the Global MSAT function strategy in cell therapy... ...and ensuring compliance with regulatory submissions. Applicants should have 12+ years of experience... ..., and a proven record in building and leading high-performing teams. The attractive...Regulatory- ...in Gaithersburg, Maryland is looking for a Director of Regulatory Affairs Strategy to guide the global regulatory path for innovative cell and gene therapies... ..., excellent communication skills, and the ability to lead complex programs in a rapidly changing environment. #J...Regulatory
$211.58k - $317.37k
AstraZeneca is seeking a Senior Regulatory Affairs Director to lead the global regulatory strategy for complex products. This role is crucial for securing rapid approvals in alignment with market and patient needs. The ideal candidate will have at least 10 years of regulatory...Regulatory$218.06k - $327.09k
AstraZeneca is seeking a Senior Director for Regulatory Affairs Strategy in Gaithersburg, Maryland. This key role will lead the global regulatory vision for innovative cell and gene therapies. You will shape strategies for complex multi-indication programs, ensuring efficient...Regulatory- AstraZeneca is seeking a Global Study Manager for its Cell Therapy team based in Gaithersburg, MD. You will support cell therapy clinical studies, ensuring quality and compliance while managing third-party vendors and internal staff. The ideal candidate holds a Bachelor...
$183.41k
...role focusing on technical oversight of donor-funded projects related to Pharmacovigilance. This position involves engaging with regulatory agencies to enhance the PV legal framework while supporting new business development opportunities in related areas. The ideal candidate...RegulatoryFull timeRemote work$242.55k - $404.25k
...clinical delivery at scale. As Disease Area Lead covering Hepatology, Renal and... ...clinical portfolio from design through regulatory submission/approvals. Define and oversee resourcing... ...Significant senior leadership experience in global clinical operations, with a track...RegulatoryLocal areaImmediate start$112k - $168k
...nature of the clinical program or study. As a Global Study Manager, you will contribute to the development of study documents, lead the preparation of country-specific... ...andassistingin the implementation of audits and regulatory inspections. You will be based in Gaithersburg...RegulatoryTemporary workLocal area$245k - $392k
...The Department Lead Scientific Communications will build and... ...scientific communications, shaping global publication strategies, and... ..., Clinical, Medical Affairs, Regulatory, Commercial) to ensure... ...messaging with regulatory labeling, submissions, and health authority...RegulatoryFreelanceWorldwide- AstraZeneca GmbH seeks a Senior Global Medical Affairs Lead in Gaithersburg, Maryland. In this pivotal role, you will shape and deliver the Global Medical Strategy within the Oncology Business Unit, driving patient experience and business impact. The ideal candidate will...
- AstraZeneca is seeking a Global Clinical Program Lead in Gaithersburg, MD, to oversee a complex prostate cancer cell therapy program. You will guide study design, monitor trials, and ensure productive engagement with external regulators and partners. The ideal candidate...
- ..., all the way to late-stage trials leading to drug approval by regulatory agencies (Phase 1, 2 and 3 trials).... ...are looking for a highly qualified Global Clinical Program Lead (GCPL) candidate... ...candidate will lead all regulatory submissions. Accountable for the clinical...RegulatoryHourly payTemporary work
- 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
$233.59k - $350.38k
Introduction to role Senior Global Clinical Operations Program Director (Sr GPD) Join... ...development plan. As a Sr GPD you will lead and manage all clinical operations deliverables... ...operations component deliverables of regulatory submissions, supporting regulatory interactions and...RegulatoryTemporary workWork experience placement- Creative Financial Staffing, LLC is seeking a Compliance Specialist - Regulatory / HR to shape and strengthen regulatory strategies within a collaborative environment. This role offers great benefits, including 100% healthcare for the employee and a hybrid work schedule...Regulatory
- AstraZeneca is seeking a Global Clinical Program Lead (GCPL) to lead clinical development strategies for hematology therapies. The successful candidate... ...the clinical strategy for multiple projects, ensuring regulatory compliance and successful execution across various phases...Regulatory
- ...Global Development Medical Director, Hematology Location: Gaithersburg... ...more than one of the world's leading pharmaceutical companies.... ...Good Clinical Practice and regulatory requirements. Responsible... ...of regulatory and EC/IRB submission documents for instances where...RegulatoryWork at officeLocal areaWorldwide3 days per week
- AstraZeneca is seeking a Statistical Science Director to lead innovative statistical strategies in clinical development. In this pivotal role, you will guide statistical thoughts for regulatory strategies, ensuring high-quality decision support. Engage cross-functionally...Regulatory
- ...qualified Study Start-up Associate Senior to join its US Remote team. The role involves preparing regulatory documents and driving site activation in alignment with global standards. You’ll coordinate activities across sites and ensure compliance with regulations. Ideal...RegulatoryRemote jobFlexible hours
- ...oversee and administer the compliance program, ensuring adherence to regulatory requirements while providing strategic leadership. The ideal... ...services sector. This role provides an opportunity to lead a team of compliance professionals and engage with regulatory authorities...Regulatory
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