Senior Manager/Manager, Regulatory Affairs
Scorpion Therapeutics
Role Associate Director/Senior Manager, Regulatory Affairs, based in Germantown, MD, supporting global drug development and regulatory strategies. Responsibilities manage daily regulatory activities for investigational and commercial drugs serve as liaison with FDA and international agencies develop and execute regulatory strategies aligned with development and marketing goals contribute to IND/BLA preparation review technical documentation monitor evolving regulations Collaborate with cross-functional teams across quality, CMC, preclinical, and clinical programs to ensure compliance and risk mitigation Qualifications bachelor's degree in life sciences (advanced degree preferred) 5+ years in biotech/pharma regulatory affairs deep knowledge of global regulations experience with eCTD submissions High Value regulatory strategy for biologics/pharmaceuticals IND/BLA submissions global compliance cross-functional collaboration risk management Work Setup office-based with some lab and manufacturing access; some travel required. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 10 hours ago
Similar jobs that could be interesting for youBased on the Senior Manager/Manager, Regulatory Affairs in Germantown, MD vacancy
- ...AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful regulatory strategies in a dynamic pharmaceutical environment.... ...in a hybrid work setting.Job DescriptionSenior Manager Regulatory Affairs OverviewThe Senior Manager Regulatory Affairs will lead regulatory...Senior
- POSITION SUMMARY: Based in Germantown, Maryland Precigen is seeking a highly motivated and experienced Associate Director/Senior Manager, Regulatory Affairs(level based on candidate experience). This role is responsible for knowledge and application of global regulations...SeniorWork at office
- ...PharmaceuticalsSelling Points Lead impactful regulatory projects at a dynamic organization with... .... Enhance your expertise in regulatory affairs and CMC compliance.Job... ...and post-approval stages.Coordinate and manage scientific and regulatory submissions, including...Senior
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta... ...enable decisive, data-driven choices.Delivery and Milestone Management: Oversee all regulatory deliverables and milestones,...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- Senior Director, Regulatory Affairs Full details of the job. ImmunocoreSenior
- The Senior Manager, Global Promotional Regulatory Affairs is responsible for providing regulatory leadership and guidance for promotional, medical, and other external communications while supporting the development and maintenance of product labeling for assigned products...Senior
- ...from all over the globe. As a Senior RegulatoryAffairs Director... ...implementation of the global regulatory strategy for a product/group... ...aspirations and update senior management on project risks/mitigation activities... ...regional regulatory affairs staff to influence developingviews...SeniorHourly payTemporary workFlexible hours
- Your Role: The Sr. Manager, Trade Compliance & Logistics is a strategic leadership role... ...from Germany to the United States. Drive Regulatory/ Operational Oversight: Oversee import/export... ...chain, quality, legal and Regulatory Affairs to ensure timely and compliant product...SeniorFull timeLocal area
- AstraZeneca GmbH in the United States is seeking a Senior Regulatory Affairs Director to lead global regulatory strategy for complex products, driving... ...chair the Global Regulatory Sub-team with regional input, manage regulatory milestones, and mentor RAD/ARAD staff across...Senior
- AstraZeneca in Gaithersburg, MD seeks a Senior Quality Leader to oversee the quality systems for commercial combination products and... ...devices. You will drive design transfer, process validation, and regulatory compliance while building a high-performing team. You will...Senior
- Roberts Oxygen is seeking a Safety & Compliance Manager to cover our Northern territory, located in Gaithersburg, MD. The role supports multiple locations and drives safety and regulatory compliance across the region. You will implement safety programs, conduct audits,...SeniorLocal area
$250k - $272.02k
...Your Role: The role will lead the team of global CMC RA managers and as the global regulatory expert for Chemistry, Manufacturing & Controls (CMC)... ...in Chemistry, Manufacturing & Controls (CMC) Regulatory Affairs for Cell & Gene Therapy (CGT) products is mandatory....SeniorFull timeWork at officeLocal areaWorldwide$139.45k - $198.72k
...inclusive and collaborative work environment.Brief Job Overview The Senior Manager, Global Trade Compliance is a hands-on managerial role... ...exposure, tariffs, and build longer-term plans to address emerging regulatory changes. This individual will take a strategic view to...SeniorFull timeWork at officeImmediate startWorldwide$208.06k - $262.15k
...prioritizes scientific integrity, regulatory excellence, and evidence-... ...training in equitable management practices and tools to promote... ...regulatory and laboratory programs Senior Pharmacovigilance... ...SENIO003504Job Category: Ext. Affairs, Regulatory, \& CommunicationsSchedule...SeniorFull timeWork experience placementWork at officeWorldwide$137.7k - $210k
...contribute to the success of the organization. Summary of PositionThe Senior Manager, Quality Systems develops, maintains, and improves the... ...control, SCARs and product complaints.Supports and may host regulatory inspections and partner audits.Perform other quality duties...SeniorFull timeCasual workLocal areaFlexible hours- BLH Technologies is seeking an experienced Senior Program Integrity & Compliance Manager to support a federal client within the U.S. Department of Health... ...program performance, fiscal stewardship, and regulatory compliance. Work You'll Do Lead compliance review engagements...SeniorContract workLocal area
- InterAgency Inc. in North Bethesda, MD, seeks a seasoned HR Manager to design and run a full-cycle recruiting pipeline in the credential-driven A/E industry, while owning employee relations, compliance, and performance functions that enable our growing professional services...Senior
- A biotechnology company is seeking an experienced Program Manager in Gaithersburg, MD. This role involves leading late-stage clinical program teams, ensuring alignment on project strategies, and influencing stakeholders across the organization. The ideal candidate will...Senior
- Axle Informatics in North Bethesda, MD is seeking a Senior Contracts Administrator to manage and close out government contracts. You will draft, negotiate, and track a variety of agreements while ensuring compliance with policies and federal requirements. You will leverage...SeniorFor subcontractorWork at office
$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...decision-making. Partnering with senior leaders and global teams, you will lead... ...risks and mitigation plans to senior management.Milestone Delivery: Support delivery of...Hourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- Axtria, Inc. is seeking a Senior Leader in its AI & Data Practice to drive transformative initiatives across cloud data management, analytics, and agentic AI for life sciences clients. You will lead client engagements, ensure delivery excellence, and provide strategic...Senior
- ...cloud software and data analytics solutions for the life sciences industry, seeks a Senior Leader for its AI & Data Practice. You will spearhead transformational cloud data management, analytics, and AI initiatives for major life sciences clients, driving client engagement...Senior
- Construction Material Testing is seeking a seasoned Project Manager to own client relationships and the testing program. Responsibilities include scoping and pricing testing, scheduling field and lab resources, reviewing reports before shipment, and maintaining project...SeniorContract work
$243.59k - $365.38k
...daily life. As an integral part of global Medical Affairs organisation, Medical Evidence function drives... ...Strategy Director role at AstraZeneca is a senior epidemiologist role combining strategy, science, and people management skills. They report to the Head of Medical...SeniorTemporary workWork at officeLocal areaFlexible hours3 days per week$150k - $180k
Location Gaithersburg, MD Salary $150,000.00 USD Annually - $180,000.00 USD Annually Senior Manager, Business Strategy & Growth We are seeking a strategic business leader to oversee a portfolio of insurance and member benefit products, drive revenue growth, improve operational...SeniorRemote work- ...The Manager, Regulatory Writing, is responsible for contributing to regulatory messaging strategy and overseeing the regulatory writing for... ...submissions and business objectives. Reporting to the SVP, Regulatory Affairs, this role will work cross functionally to provide writing...
$181.6k - $272.4k
...current and future unmet needs, while providing strategic counsel to senior leadership on high-impact and complex topics. Business... ...communication skills Effective interpersonal and relationship management skills with consultative approach and ability to interact and...SeniorHourly payTemporary workWorldwideFlexible hours- ...future of oncology medicines and influence regulatory decisions that impact patients globally?... ...-changing medicines. As a Regulatory Affairs Director, you will play a pivotal role in... ..., submission, approval and lifecycle management activities while partnering with leading...Hourly payFull timeTemporary workWorldwide
- AstraZeneca in Gaithersburg, MD, seeks a Director Regulatory Intelligence (RID) to translate emerging regulatory signals into choices for... ...supporting strategy and portfolio decisions. You will partner with senior leaders and cross-functional groups to shorten timelines,...
- Precigen, based in Germantown, MD, seeks a Senior Manager/Manager, Regulatory Affairs to lead regulatory strategies for drug development programs, guiding IND/BLA submissions and regulatory intelligence. The role works with QA, CMC, Preclinical and Clinical teams to ensure...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Manager/Manager, Regulatory Affairs. Be the first to apply!
Related searches
- senior consulting engineer Germantown, MD
- senior medical science liaison Germantown, MD
- senior software engineer remote Germantown, MD
- senior mulesoft developer Germantown, MD
- senior performance engineer Germantown, MD
- senior manager m&a tax Germantown, MD
- senior living Germantown, MD
- senior performance tester Germantown, MD
- senior international accountant Germantown, MD
- senior sas developer Germantown, MD