Regulatory Writing Senior Manager
$139.58k - $188.85kAmgen Inc
Amgen seeks a Regulatory Writing Senior Manager to lead regulatory submission activities for pharmaceutical and biologics products. The role involves authoring complex regulatory documents, mentoring junior writers, and serving as functional area lead on cross-functional product teams.
Responsibilities
- Author or oversee authoring of regulatory submission documents including Clinical Study Reports, Investigator Brochures, and eCTD Module 2 Clinical Summary Documents
- Lead regulatory writing activities for complex product submissions including new and supplemental drug/biologics license applications
- Serve as functional area lead on global product teams and provide regulatory writing expertise
- Supervise and mentor contract, freelance, and junior medical writers on assigned projects
- Conduct formal review and approval of authored documents per applicable standard operating procedures
Requirements
- Doctorate degree plus 2 years directly related experience, or Master's plus 6 years, or Bachelor's plus 8 years, or equivalent
- Experience with regulatory documents in Regulatory Affairs, Research, Development, or related field
- 5+ years medical writing experience in Biotech/Pharmaceutical industry
- Demonstrated leadership and mentoring capabilities
- Expertise in clinical submission document preparation and regulatory processes
Compensation: $139,581.90–$188,846.10 USD
Vacancy posted 12 days ago
Similar jobs that could be interesting for youBased on the Regulatory Writing Senior Manager in Remote vacancy
- ...Senior Manager, Contracts Aon Vietnam is currently looking for a Senior Manager, Contracts... ...issues and emerging trends and changes in regulatory landscape in Vietnam that would impact... ...leaders. Good contracts drafting and writing skills. Strong negotiation and stakeholder...SeniorRegulatoryContract workPrivate practiceLocal areaRemote work
Aon
United States3 days ago $155k - $200k
...Senior Manager, Biostatistics BeOne continues to grow at a rapid pace with challenging and... ...position will work with the clinical and regulatory team in designing clinical trials and... ...operation, clinical pharmacology, medical writing and other functions. This position will...SeniorRegulatoryHourly payWork experience placementLocal areaRemote workAvery Healthcare Group Ltd.
United States1 day ago- Integral Consulting Inc. is seeking a senior wildlife ecologist and project manager to lead environmental and... ...ecological expertise, and navigate regulatory requirements to deliver compliant,... ...role emphasizes strong technical writing, field coordination, and collaborative...SeniorRegulatoryRemote job
- ...diseases. See Yourself at Telix The Senior Manager, Clinical Quality will be part of a... ...with the protocol, GCP and the applicable regulatory requirement(s). The Senior Manager,... ...monitoring organizations and other vendors by writing audit plans, audit agendas and audit...SeniorRegulatoryFull timeRemote work
- Position Title: Senior Director - Legal Services Department: Executive... ...of interest. This position manages and supports NSBA’s Council... ...amicus brief development, regulatory comments, and legal publications... ...in legal research, legal writing, regulatory analysis, and public...SeniorRegulatoryWork at officeRemote work
- ...everywhere. Apply today! Job Details The Senior Category Manager is responsible for developing and... ...the filing pathways to obtain regulatory approval and is familiarity with FDA... ...communicate effectively both orally and in writing Strong interpersonal/relationship...SeniorRegulatoryFull timeContract workLocal area
- ...Senior Product Marketing Manager - Sovos SOVOS Senior Product Marketing Manager-Pricing Product... ...complex and rapidly changing regulatory environments with confidence - and helping... ...communicate exceptionally well in writing and verbally, with strong presentation...SeniorRegulatoryFull timeRemote workFlexible hours
Sovos Compliance
United States2 days ago $85k - $105k
...About the Role The Senior Manager, Federal Policy leads the day-to-day execution and shapes... ...partners, and SHC’s broader network. Write issue briefs, public comments, position... ...federal legislative, administrative, and regulatory processes. Substantial knowledge of...SeniorRegulatoryFull timeLocal areaRemote workWork from homeFlexible hoursShift work- ...Field Engineers use. We are looking for a Senior Product Manager to lead continued improvements to the... ...customer needs, technology changes, regulatory drivers, and business impact.... ...staff. Validate real problems before writing a single requirement. Working with...SeniorRegulatoryPermanent employmentFull timeRemote workRelocation packageShift work
- ...Senior Product Marketing Manager, AI Security Varonis Atlas | Location: New York or Remote (U.S.) | Marketing... ...in enterprise workflows, reading, writing, and acting on data at machine speed... ...AI security buyers, market trends, regulatory shifts, and competitive offerings,...SeniorRegulatoryRemote workShift work
Varonis
United States3 days ago - ...preparation of financial statement and regulatory filings, and the application and implementation... ...the areas of financial reporting, risk management, and compliance to help address our... ...deliverables Train managers and staff Writing/developing client reports/deliverables...SeniorRegulatoryRemote workFlexible hours
Myers and Stauffer
Boston, MA2 days ago $175k - $250k
...com ( What you'll be doing As a Senior Relationship Manager, you’ll focus on growing direct revenue... ...or large groups, with excellent writing skills to craft professional proposals... ...thorough understanding of operational, regulatory, and compliance requirements. Values...SeniorRegulatoryFull timeRemote workCIBC
New York, NY2 days ago$130k - $170k
...Inc. is seeking an experienced Senior Environmental Planner who... ...role combines strategic project management skills with technical... ..., lead proposal strategy and writing, prepare interview materials,... ...staff in environmental planning, regulatory compliance, and project management...SeniorRegulatoryTemporary workWork at officeLocal areaRemote workGAI Consultants
Austin, TX1 day ago- ...who do it. Position Summary The Senior Manager of Biostatistics is a member of cross-functional... ...of results, and preparation of regulatory submissions. These individuals develop... ...Good interpersonal, communication, writing and organizational skills Ability to...SeniorRegulatoryHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours
Bristol-Myers Squibb Company
Princeton, NJ23 hours ago $110.57k - $121.5k
...Position Title: Senior Contracts Manager Department : Legal, Compliance and Risk Management Location... ..., external investigations and regulatory matters, as needed. -Conduct legal research... ...agreements. -Excellent legal research and writing skills. -Strong prioritization and...SeniorRegulatoryPermanent employmentFull timeContract workInterim roleRemote workAmeriCares Foundation
New York, NY2 days ago- ...Senior Project Controls Manager ProSidian is a Management and Operations Consulting Services firm that... ...request tracking; report writing; Excel-based analysis; stakeholder coordination... ..., Commercial, Environmental, Regulatory, Construction, and Operational perspectives...SeniorRegulatoryContract workFor contractorsWork at officeRemote work
ProSidian Consulting
United States23 hours ago - ...models, and who is equally comfortable writing a threat model, breaking a system in a red... ...and SLSA-aligned build integrity, CVE management, dependency and license governance. Own... ...delivering under compliance, security, or regulatory constraint with audit-grade evidence...SeniorRegulatoryContract workSummer holidayImmediate startFlexible hours
- ...scientific approach to complex trial data and regulatory submission challenges. With a global... ...processing, narrative and/or safety writing. Understands clinical trial processes.... ...in related deliverables Independently managing/leading client meetings and CRMs for effective...SeniorRegulatoryRemote job
$130k - $170k
...Inc. is seeking an experienced Senior Environmental Planner who... ...role combines strategic project management skills with technical... ...with strong CEQA/NEPA‑related regulatory knowledge and proven success... ..., lead proposal strategy and writing, prepare interview materials,...SeniorRegulatoryContract workTemporary workWork at officeLocal areaRemote workGAI Consultants
Denver, CO4 days ago- ...and compete. About the role Title: Senior Product Marketing Manager Function: Marketing Reports to: Director... ...sciences Translate technical and regulatory concepts into crisp, differentiated... ...a claim isn't supported Exceptional writing and storytelling: you can make complex...SeniorRegulatoryRemote work
LeapXpert
New York, NY4 days ago $121.08k
...International Union) Job Title: Senior Campaign Coordinator Grade... ...communities; to direct and manage multi-component,... ...relevant political, legislative or regulatory strategies and tactics. Ability... ..., both orally and in writing; ability to make formal presentations...SeniorRegulatoryWork at officeLocal areaRemote workCurrent SEIU
Washington DC2 days ago- ...creates unnecessary administrative work, regulatory risk, and higher costs across the... ...About the role: We are seeking a Senior Manager of Brand Marketing to own Certify's brand... ...podcasts, or video programs. ~ Strong writing and editorial skills - able to produce...SeniorRegulatoryRemote work
CertifyOS
United States1 day ago $110k - $150k
...This Role Makes a Difference The Senior Manager, Member Experience Marketing will lead... ...content across channels and formats. Write, edit, and oversee content for email,... ...literacy, accessibility, privacy, regulatory, and compliance requirements. Partner...SeniorRegulatoryFull timeTemporary workWork at officeLocal areaRemote workWorldwideVisa sponsorshipWork visaFlexible hours- ...Environmental Services, Inc. is seeking a Senior Environmental Project Manager to join and report through its... ...management responsibilities and regulatory interaction; \n Demonstrated experience... ...the preparation, organization, writing, and editing of reports, draft...SeniorRegulatoryFor contractorsFor subcontractorWork at officeLocal areaHome office
KEMRON Environmental Services
Marietta, OH14 days ago - ...data residency, sovereignty and regulatory requirements of UK and... ...including the EU AI Act Leverage senior-level relationships with... ...building a territory rather than managing an inherited one ~ A proven... ...-party services (e.g., CV writing) as part of our hiring process...SeniorRegulatoryFull timeWork at officeLocal areaRemote workHome office
Cohere
United States2 days ago $100k - $175k
...focused Drinking Water Project Manager to join our growing Water... ...master planning initiatives, regulatory compliance programs, and capital... ...for projects. Partner with senior leadership to develop technical... ...funding programs. Excellent writing, communication, and presentation...SeniorRegulatoryContract workFor contractorsFor subcontractorLocal areaRemote workRelocation packageFlexible hours- Job Title: Senior Project Manager (Hybrid/On-Site) Location: McLean, VA Company: BLN24 About Us:... ...delivery programs, coordinating between regulatory and technical teams, and sustaining... ...coordinate between Bureau regulations-writing staff and the technical team Facilitate...SeniorRegulatoryWork at officeRemote work
- ...Senior Enterprise Account Executive The Senior Enterprise Account... ...established with the management team. Establish and nurture... ...understanding the clinical and regulatory landscape, including best practices... ...necessary for computer work, writing, and telephone use, supported...SeniorRegulatoryWork at officeLocal areaRemote workFlexible hours
Urban Ridge Supplies
United States4 days ago $150k - $210k
...wastewater treatment, stormwater management, and delivery system design,... ...’ll Be Challenged To Do As a Senior Project Manager - Area Leader... ...with municipalities and regulatory agencies. Oversee construction... ...Demonstrate professional technical writing and verbal communication...SeniorRegulatoryFull timeContract workWork at officeRemote work$200k - $250k
...GFT is seeking a Senior Construction Manager/ Resident Engineer to support our growing construction... ...procurement delays, quality deficiencies, regulatory non-compliance, environmental non-... ...Excellent interpersonal, communication, writing, team leadership, and conflict...SeniorRegulatoryFull timeContract workFor contractorsRemote workFlexible hoursGFT
Riverside, CA23 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Writing Senior Manager. Be the first to apply!
Related searches
- head compliance Remote
- corporate compliance manager Remote
- regulatory & compliance manager Remote
- director regulatory affairs cmc Remote
- regulatory affairs manager pharmaceutical Remote
- associate director compliance Remote
- regulatory affairs director Remote
- director quality compliance Remote
- manager regulatory affairs Remote
- quality compliance manager Remote