Global Regulatory Affairs Lead — Drug Development & Submissions
$200k - $220kPrecigen
Precigen is seeking an Associate Director/Senior Manager, Regulatory Affairs in Germantown, MD. The role involves managing regulatory affairs for investigational and commercial products and ensuring compliance with global regulatory requirements. The ideal candidate should possess a bachelor's degree in life sciences, five years of relevant experience, and strong analytical and leadership skills. This position offers a full-time opportunity with a salary range of $200,000.00 to $220,000.00 annually. #J-18808-Ljbffr Precigen
$186.23k - $279.35k
AstraZeneca in Gaithersburg, Maryland is seeking a Regulatory Affairs Director to lead global regulatory strategies for drug development. The position demands a strong background in regulatory affairs, with a focus on delivering innovative medicines while strategically...Suggested- A global healthcare company is seeking an Associate Director, Biostatistician... ...provide statistical expertise in drug development. The role involves leading statistical analysis and... ...pharmaceutical industry, strong knowledge of regulatory requirements, and proficiency in...Suggested
- ...Maryland, is seeking a Vaccines Manager of Global Regulatory Affairs to support the regulatory strategy... ...affairs experience. You will lead strategic initiatives and ensure compliance... ...teams, and ensuring timely submissions to regulatory agencies. #J-18808-Ljbffr...Suggested
$146.3k - $234.1k
...You will be a member of the Global Labeling, Global Regulatory Affairs team and will lead all Labeling activities required for the development and maintenance of the Company Core Data Sheet, US prescribing and patient information and EU CP prescribing and patient...SuggestedHourly payWork experience placementLocal areaRemote workWorldwide- The National Society for Black Engineers is seeking a Global Regulatory Affairs Manager in Rockville, MD. The role focuses on executing global regulatory strategies for oncology assets while ensuring compliance with internal and external requirements. The ideal candidate...Suggested
- ...Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution... ...for the development, implementation and... ...according to regional and global Business Objectives... ...programs. Acting as submission sub-team lead for US... ...knowledge of US drug development and regulatory...Hourly payTemporary workWork at officeFlexible hours3 days per week
- ...are seeking a Medical Lead, Prostate Cancer to join US Medical Affairs in Gaithersburg, Maryland... ..., partner closely with Global Medical Affairs , and... ...including medical, prescription drug, dental, and vision... ...approach to our development. Date Posted 10-Jun...Hourly payTemporary work
$193.28k - $289.92k
...Medical Lead, Breast Oncology Franchise At AstraZeneca... ...sharp focus on talent development, there is an exciting... ...for leading Medical Affairs activities in Breast Oncology... ...-country, regional, or global organizations is... ...Experience with pharmaceutical drug development and Medical...Temporary workWork experience placementWorldwide$112k - $168k
AstraZeneca is seeking a Global Study Manager in Gaithersburg, MD to oversee cell therapy clinical studies, ensuring quality and compliance. The role involves managing vendors, developing study documents, and supporting various strategies to deliver studies effectively...$85k - $110k
...Maryland seeks a skilled Federal Proposal Specialist to oversee the development of compliant proposals for U.S. Government contracts. This hybrid role involves collaborating with teams to ensure timely submissions that meet FAR standards. The ideal candidate has 5-10+ years...- USP is seeking a Program Manager to manage ongoing projects supporting biological standards development in Rockville, Maryland. The successful candidate will lead collaboration efforts and ensure operational alignment across projects. This role requires a Bachelor’s degree...
- 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...
$91k - $147.2k
...Companies is recruiting for an MTST Global Finance Reporting Lead - Endomech and Energy to be located... ...will be considered as a single submission. At Johnson & Johnson,we believe... ...mitigating actions, if needed Support development of an audit-proof system for transformation...Full timeTemporary workLocal areaRemote workWorldwide- ...and passion for Medical Affairs in Oncology ?... ...are seeking an Asset Lead, Oncology Outcomes Research... ...strategies and studies on a global and US market level. The... ...'ll Do: ~ Leads the development and execution of the Global... ...medical, prescription drug, dental, and vision...Hourly payTemporary workShift work
- ...Senior Global Medical Affairs Leader, Amyloidosis Location: Gaithersburg... ...critical role in developing and leading global product and disease... ...role, you will lead the development and implementation of global... ...medical, prescription drug, dental, and vision coverage...Hourly payTemporary work
- ...curiosity, for Medical Affairs in Oncology? Apply your... ...(GU) Cancers team, the Global Medical Affairs Leader... ...play a key role in the development of medical strategy and... ...~ Serve as Strategic Lead for Advisory boards including... ...Good understanding of drug development and...Hourly payTemporary work3 days per week
- 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...
- ...in Gaithersburg, Maryland is seeking an experienced professional to provide technical leadership for Operational Technology (OT) in global engineering projects. You will guide the design and implementation of innovative automation solutions supporting Industry 4.0 and...
- What you’ll do Lead the Global Product Team (GPT) which together defines and drives the strategic... ...the lifecycle including clinical development, regulatory approvals, product launch/... ...or late stage) as a core team member. Drug development and regulatory/filing experience...Hourly pay
$193.28k - $289.92k
...all our products. BPM aims to lead AZ in achieving scientific... ...medicines and market-shaping teams globally. As a key member of the... ...immersion of global KEEs in pipeline development across R&D Work with MCs to... ...medical, prescription drug, dental, and vision coverage...Temporary workLocal areaImmediate startWorldwide- ...clinical research organization is seeking a Proposal Manager to lead proposal development for U.S. government projects. This fully remote role... ...collaboration with various departments to ensure high-quality submissions. Ideal candidates possess a Bachelor's degree and at least...Remote jobFlexible hours
$245k - $392k
...The Department Lead Scientific Communications... ...that spans early development (Phase I) through... ..., shaping global publication strategies... ...Head of Medical Affairs. Your... ...Medical Affairs, Regulatory, Commercial) to... ...regulatory labeling, submissions, and health...FreelanceWorldwide- AstraZeneca in Gaithersburg, MD is seeking a Global Medical Affairs Lead to drive oncology strategy and execution. This pivotal role connects R&D with commercial initiatives, owning the medical strategy for cancer treatments. The ideal candidate will possess an MD, PhD,...
- A technology company in Germantown is seeking a Senior Mechanical Engineer to lead the design and development of mechanical systems and components. This role involves collaboration across teams, mentoring younger engineers, and ensuring compliance with technical standards...
$65k - $90k
...Description Are you driven to grow, lead, and make a meaningful impact? At Apex,... ...growth, which is why we invest in your development at every stage of your career. Here, you... ...preferred ~ Experience with permitting or regulatory coordination is a plus ~ Experience...Temporary workWork at officeNight shift- ...Clinical Scientist will lead a group of clinical... ...Hematology Research and Development and will serve as a member... ...with GCP and relevant regulatory guidelines. Essential... ...of GCP and end‑to‑end drug development (Phases I-III... ...Hematology‑Oncology. Global study leadership: Significant...
$22 - $26.5 per hour
...and inclusive team culture, fostering associate engagement and development. Ensure compliance with company policies, procedures, and... ...qualify. View player benefits here. EEO Statement Topgolf is a global sports and entertainment community and is committed to equal...Work experience placementShift workAfternoon shift- ...Public Policy and Strategic Engagement Lead supporting the U.S. Navy's Submarine Industrial... .... This position will be leading the development, coordination, and analysis of... ...background in maritime policy, legislative affairs, and strategic engagement across both the...Full timeContract workPart timeFor contractorsWork at officeLocal areaImmediate startWork from homeFlexible hours
- ...Oncology Medical Lead is a key role within... ...Oncology Medical Affairs (USMA) organization... ...supporting the development of the Medical strategy... ..., R&D and Global Medical Affairs.... ...latest technical, regulatory, policy and patient... ...with pharmaceutical drug development and Medical...Hourly payTemporary work
- Guardian Fire Protection Services, LLC is seeking a Communications Manager to lead the development and execution of internal and external communications, including newsletters and marketing collateral. The ideal candidate will have over 5 years of experience in communications...Full time
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