Regulatory Affairs CMC Lead - Gene Therapy (Hybrid)
Jobleads-US
CRISPR Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience in CMC regulatory requirements for biologics and gene therapies.
The ideal candidate will have over 12 years of regulatory experience and a strong understanding of FDA and EMA guidelines, with a proven record of successful submissions. This position promotes a collaborative work environment with flexible remote options.
#J-18808-Ljbffr Jobleads-US$212k - $333.19k
...and delivers transformative therapies to patients. By focusing R&D... ...as a Senior Director, Global Regulatory Lead - Oncology, where you will... ...concepts within regulatory affairs and implications across the... ...is currently classified as "hybrid" following Takeda's Hybrid and...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide- Ellie Mental Health in Newton, MA is seeking licensed mental health counselors (LMHC) for a hybrid role that aims to ignite creativity while reducing traditional therapy barriers and offering strong support. You will supervise other counselors, evaluate diagnoses, craft...SuggestedFull timeFlexible hours
- Sarepta Therapeutics seeks an Associate Director, Global Medical Affairs Lead (GMAL) to drive medical strategy and tactics for Duchenne gene therapy programs. This role aligns GMA initiatives with corporate priorities, develops scientific communications, and reviews medical...Suggested
$204k - $281k
About This Role:As the CMC Asset Lead, you will be an integral part of the PO&T Nephrology team, focusing on the development and launch of... ...that are essential for the company's strategic goals.This is a hybrid role that can be based in any of our US offices (RTP, NC or Cambridge...SuggestedFull timeTemporary workLocal area$151.2k - $226.8k
...synthetic lethality to discover and develop therapies that take aim at critical targets in... ...into novel areas such as tumor suppressor gene loss and their contribution to the ability... ...time, overdue items, training compliance)Lead QMS simplification/optimization, including...Suggested- Biogen, Inc. seeks an experienced CMC Asset Lead at Associate Director level to guide end-to-end asset leadership for clinical programs.... ...process development, manufacturing, quality, supply chain and regulatory CMC, driving strategic planning and risk management in a collaborative...
- ...Pharmaceuticals seeks a Principal Business Analyst for Cell & Gene Therapy Commercial Technology to translate business needs into functional... ...scalable data and analytics solutions supporting patient journey and order management, with hybrid work options. #J-18808-Ljbffr
$173.2k - $216.5k
...diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re... ...Associate Director, Global Medical Affairs Lead (GMAL) is a key contributor to the... ...to apply.#LI-HybridThis position is hybrid, you will be expected to work on site...Full time- ...(AOC) purification as well as lead program(s) with the goal to enable... ...Concept transition by leading CMC team as necessary for the... ...Development, Formulation Development, Regulatory, Technical Operations, Quality... ...lead for biologics or complex/hybrid modalities.Excellent...Full timeTemporary workLocal areaFlexible hours
- ...join our Cambridge, MA team with full relocation provided. This hybrid role requires a minimum of 3 days in the Reston, VA or... ...personnel to maintain GFP processes, supervise staff, and ensure regulatory alignment with FAR and DFARS guidelines. #J-18808-Ljbffr Job JunctureRelocation
$122.25k - $176.58k
Job Title: CMC Demand & Supply LeaderLocation: Framingham, MAAbout... ...of Projects in respect to Regulatory and Quality requirements.... ...decisions and budget definition.Co-lead Demand & Supply Sub Team and... ..., Immuno-inflammation, Gene Therapy, Rare Diseases, Pharmaceutical...Full time$144.06k - $205.8k
...patients. We provide transformative therapies in disease areas that include... ...operational readiness. The Lead, Access Marketing, IZERVAY is... ...and applicable legal, regulatory, privacy, and promotional requirementsJob... ...and we are proud to offer a hybrid working solution allowing...Work at officeRemote workWork from homeWorldwide$130k - $170k
...adding an experienced Environmental Siting Lead to support and expand our routing, siting... ...extensive knowledge of permitting and regulatory processes throughout New England, particularly... ...: Flexible within New England (Remote or Hybrid)Why Tetra Tech:At Tetra Tech, we are...Contract workFor contractorsWork experience placementWork at officeLocal areaRemote workWorldwideFlexible hours$148.5k - $214.5k
...2855379 Job title : CMC dossier leader ~ Location... ...and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable... ...development and/or regulatory affairs AI applications and... ...#LI-SA #vhd #LI-Hybrid Pursue progress...Full time$83k - $123k
...ignite their creativity while minimizing the barriers that come with traditional therapy practices. Note--this is a hybrid position, not a 100% remote position. As a supervising Lead Marriage and Family Therapist at Ellie Mental Health’s locally owned and...Full timeWork at officeLocal areaFlexible hours$212k - $333.19k
...Director, Global Program Lead- Neuroscience in our... ...driving regulatory approval as well as launch... ...modalities such as Cell Therapy or Gene Therapy, large scale programs... ...Pharmaceutical Sciences (CMC) Subteam, etc. to the... ...classified as “ hybrid” in accordance with Takeda...Minimum wageTemporary workWork at officeLocal areaRemote work- ...Assurance to oversee QC and analytical development activities across Cell & Gene programs. You will drive QA oversight of method validations, transfers, and stability programs, while leading audits and CAPA processes to ensure FDA/EMA compliance. The role emphasizes...Contract work
$154.4k - $242.55k
...DescriptionThe Plasma-Derived Therapies (PDT) R&D Organization is... ...MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma... ...regulatory strategy, medical affairs, etc.). 5-7 years of... ....Location: Cambridge, MA (Hybrid)Takeda Compensation and Benefits...Minimum wageTemporary workLocal area$99k - $167k
As a Lead Product Advisor supporting Commercial Farm Ranch you will provide the product... ...knowledge of market research and marketplace and regulatory trends. •Extensive knowledge and... ...position unless specified in the postingIn this hybrid role, you will be expected to work a...Full timeLocal areaRelocation package$111k - $189k
The Lead Strategic Partnership Data Analyst turns data into clear, actionable insights that support National Accounts. You will identify... ...apply and should review the internal mobility guidelines in the hybrid policy reference guide for more information on potential...Full timeWork at officeLocal areaRelocationRelocation packageFlexible hours$328k
...Medical Director, Global Medical Lead (GML), Pain is a critical... ...will lead the global medical affairs team for the designated disease... ...literature, etc.) for pipeline therapies and marketed medicines Regional... ...so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...Full timeSummer workRemote workFlexible hours2 days per week$70k - $80k
...candidates should have outreach experience, a bachelor’s degree in relevant fields, and strong communication skills. This position offers a hybrid work schedule with a salary range of $70,000 - $80,000 based on experience. #J-18808-Ljbffr Massachusetts Institute of Technology- Sarepta Therapeutics, Inc. is seeking an experienced MSL Team Lead to develop the regional MSL strategy and lead a high-performing field... ..., and a deep knowledge of neuromuscular diseases. This hybrid position is based in the United States with on-site involvement...
- Hongene Biotech is seeking an Associate Director / Senior Manager in CMC Project Management in the Boston area. The role reports to the VP, Global Head of CMC & Regulatory and strengthens project management for oligonucleotide contract manufacturing services. Senior/AD...Contract work
- Alnylam Pharmaceuticals, Inc. seeks an Associate Director in Program Management. This hybrid role in Cambridge, MA, focuses on driving the strategy and execution of drug development programs, particularly in CNS. Candidates must have 8+ years in the pharmaceutical industry...
- ...Pharmaceuticals is seeking an Associate Director to lead downstream development for emerging... ...Conjugate purification. You will guide CMC strategy and partner with CDMOs to... ...define control strategies, and contribute to regulatory submissions while coordinating with cross...
- Sanofi Inc. in Framingham, MA seeks a CMC Demand & Supply Leader to unify Clinical, CMC, and Development demand into an optimized end-to-end plan across the supply chain. You will partner with Global Project Management, Clinical Development, and manufacturing stakeholders...
- ...and content. You will connect AI search performance to business outcomes and ensure the brand's trusted position in the market. This hybrid position requires in-office presence three days a week and offers an opportunity to drive significant impact in a growing digital...Work at office3 days per week
- CJ is seeking a seasoned Client Partnerships Manager to lead influencer campaigns and partner relationships. You will align client KPIs... ...to analyze data, guide budgeting, and optimize results. This hybrid role requires in-office days and offers comprehensive benefits....Work at office
- EverQuote is seeking a Senior Manager, SEM Analytics in Cambridge, MA, with hybrid in-office work three days a week. You will own SEM end to end, lead a growing analytics team, and drive measurement across campaigns using SQL to connect performance to outcomes. The role...Work at office3 days per week
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