Associate Director, Global Regulatory Science, CMC
$63.2k - $100.9kModerna
Six-month co-op position in the Clinical Biomarker Laboratory's Flow Cytometry Group, based in Norwood, MA. Contribute to assay development and optimization through laboratory experiments, data analysis, and reference dataset generation to support immune response research and clinical development activities.
Responsibilities
- Conduct facility inspections to identify maintenance needs and develop preventive plans
- Coordinate and prioritize maintenance activities with minimal operational disruption
- Troubleshoot and resolve issues with facility systems, equipment, and infrastructure
- Oversee repairs and maintenance across electrical, plumbing, HVAC, and carpentry
- Train and mentor junior technicians on safety protocols and technical skills
Requirements
- High school diploma or certificate from technical trade school
- 5-7 years of facilities maintenance or technician experience
- Knowledge of electrical, plumbing, HVAC, and carpentry systems
- Ability to troubleshoot complex facility infrastructure problems
- Experience in pharmaceutical or regulated facility environments
Compensation: $63,200 - $100,900 base salary
$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... .... We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best...SuggestedPermanent employmentFull timeWork at officeWork from home$142.5k - $256.5k
The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... .... We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best...SuggestedPermanent employmentWork at officeLocal areaWork from home$154.4k - $242.55k
...is possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as...SuggestedMinimum wageLocal areaRemote workWorldwide- Moderna is seeking an Associate Director, Global Regulatory Affairs, CMC, to lead and oversee regulatory activities for CMC and Quality, coordinating worldwide submissions and agency communications. The role requires 10+ years in pharma/biotech with strong EU/ROW regulatory...SuggestedWork at officeWorldwide
$224.9k - $404.6k
...responsible for managing a team of CMC experts that prepare and... ...related agency correspondence and regulatory applications. This position... ...That’s why our US benefits and global well-being resources are... ...to have been recognized as a Science Magazine Top Biopharma Employer...SuggestedPermanent employmentFull timeWork at officeWork from home$166.4k - $249.6k
...DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and... ..., Pharmacy, Regulatory Affairs, or related life science field (advanced degree preferred)8+ years of...Full timeSummer workRemote workFlexible hours2 days per week$166.4k - $249.6k
...Associate Director of Regulatory CMC for biologics who will lead global regulatory strategy, author and review CMC submissions for investigational and commercial products... ...Pharmacy, Regulatory Affairs, or related life science field ~8+ years pharmaceutical or...$195k - $330k
...for the past several years. For more information about our science, pipeline and people, please visit or follow us on X (formerly... ...you’ll make an impact:Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages of...- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston, MAtime type... ...to patients. As the Regulatory CMC lead for these programs, you will have... ...work in close collaboration with CMC and global development teams, and with relevant external...Contract workRemote work
$154.4k - $242.55k
...is to accelerate access to transformative medicines and make a lasting impact on patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Associate Director, Global Regulatory Lead Oncology...Minimum wageLocal areaRemote workWorldwide$230k - $260k
...Director, Regulatory CMC – Solid Biosciences Charlestown, MA Solid Biosciences... ...of uniting experts in science, technology, disease management... ...developing and executing global Regulatory CMC strategies for... ...industry consortia, trade associations, and gene therapy working...Full timeTemporary workFlexible hours$147.5k - $221.3k
Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness... ...and Skills:Knowledge of regulatory requirements and inspection expectations... ...-HybridCompany InformationVertex is a global biotechnology company that invests in...Full timeSummer workRemote workFlexible hours2 days per week$154.4k - $242.55k
...strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of... ...drafting and reviewing guidance comments and supporting trade association working groups.Education & Competencies (Technical and...Minimum wageLocal areaRemote work$200k - $265k
.... We deliver an innovative, science-based portfolio of premium flagship... ....The OpportunityLeads the global regulatory strategy, submission... ...FDAIdentify and assess risks associated with product development and... ...clinical, non-clinical, and CMC development documentation as...Full timeTemporary workWork experience placementWork at officeWorldwide$147.5k - $221.3k
...Vertex Pharmaceuticals seeks an Associate Director to lead inspection readiness... ...improvement, and ensure regulatory readiness through audits, assessments... ...~8+ years of relevant CMC quality or compliance experience ~ Knowledge of global regulatory requirements and inspection...- This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations... ...CMC intelligence activities. Responsibilities: The Associate Director, Regulatory Affairs CMC will be responsible for leading regulatory...
$167k - $300.7k
...Manufacturing, and Controls Quantitative Sciences (CMC QS) team as a Director based in Norwood, MA. In this role,... ...across the product lifecycle, from regulatory filings and lifecycle management to... ...to expand our pipeline, accelerate global impact, and uphold our values of...Permanent employmentFull timeSeasonal workWork from home$167k - $300.7k
...dynamic and experienced Director, CMC Stability to lead an... ...CMC decisions, regulatory filings, and product... ...judgment, deep stability science, and the ability to make... ...stability leads and associates, fostering a culture... ....Strong knowledge of global stability expectations...Permanent employmentFull timeWork from home$142.5k - $256.5k
The RoleThe Associate Director, Business Operations, Quality Control... ...functions for the Global Quality Control... ...Supply Chain, Finance, CMC Digital, Quality, and... ...Business, Engineering, Life Science, Industrial Engineering... ...of the work and regulatory requirements, only individuals...Permanent employmentFull timeWork at officeWork from home$142.5k - $256.5k
...Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and... ...data into actionable program, regulatory, and supply decisions.This role... ...operating within cross-functional CMC team structures.Experience in...Permanent employmentFull timeWork at officeWork from homeWorldwide$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead early-stage... ...that turns precision radioconjugate science into first-in-human reality? As... ...readiness. IND/IMPD Readiness: Lead CMC regulatory strategy; guide and contribute to...Hourly payTemporary work$218.06k - $327.09k
...you ready to set the global regulatory vision for pioneering... ...and turn breakthrough science into real options for... ...report to the Executive Director, Cell Therapy Regulatory... ...with clinical, CMC, safety and commercial... ...compliance activities associated with marketed brands,...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$142.5k - $256.5k
The Role:The Associate Director of Investigations & Operational Performance... ...issues, performance trends, regulatory intelligence, and emerging risks... ...volunteer days, sabbatical, global recharge days, and a... ...to have been recognized as a Science Magazine Top Biopharma Employer...Permanent employmentFull timeWork from home$230.72k - $345k
...Remote Full time R12948 Position Summary The Senior Director, Global Regulatory Strategy is a senior regulatory executive responsible for... ...with Clinical Development, Medical Affairs, Regulatory CMC, Quality, Safety, Commercial, Market Access, and Program Leadership...Full timeTemporary workLocal areaRemote workWorldwideFlexible hours$180k - $245k
...seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our... ...immunology background is preferred. CMC experience is a plus.... ...QualificationsBachelor's degree in health sciences or related field, or an advanced...$195k - $330k
...more information about our science, pipeline and people, please... ...ll make an impact:Act as the global regulatory strategy lead for Kymera’s IRF... ...closely with Clinical, CMC, Nonclinical, Quality, and Commercial... ...preferred but not required.Director: 8-10 years of Regulatory...Flexible hours- ...Rapport Therapeutics seeks an Associate Director of Regulatory Strategy to develop and execute regulatory... ...development programs Advise clinical, CMC, pharmacology, and nonclinical teams... ...with health authorities Monitor global regulatory landscape and communicate...
$129k - $203.1k
...Job Description The Associate Director, Regulatory Affairs, supports products in... ...and will work closely with a global regulatory lead(s) to help... ...application of regulatory science and strong communication and... ...Manufacturing and Control (CMC) as well as other functional...Full timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$160k - $240k
...information about our science, pipeline and people,... ...make an impact:As the Associate Director, Analytical Development... ...you will contribute to CMC activities supporting... ...sections of late phase regulatory submissions (e.g., IND... ...approaches meet global regulatory expectations...Contract work$180k - $205k
...We are seeking a strategic, hands-on Associate Director, Regulatory Affairs to lead regulatory project teams... ..., coupled with a strong foundation in global regulatory planning for psychiatry and... ...teams across clinical, nonclinical, CMC, and commercial functions. Serve as the...Work at office
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