Regulatory CMC Lead, Sterile Injectables & Generics
Breckenridge Pharmaceutical
Breckenridge Pharmaceutical is seeking a Regulatory Affairs Manager to support regulatory CMC strategies and submissions for generic products, including complex sterile injectables and drug-device combinations. You will prepare, review, and submit filings throughout the product lifecycle while ensuring FDA compliance and eCTD standards. Reporting to the Director of Regulatory Affairs, you will lead regulatory activities for assigned programs, collaborate with R&D, Analytical Development, #J-18808-Ljbffr Breckenridge Pharmaceutical
$173.2k - $272.6k
Job DescriptionThe Sterile Product Development group is... ...including long-acting injectables (LAIs), across small molecules... ...Non-Clinical, Quality, Regulatory, Manufacturing, and... ...to CMC regulatory submissions... ...submissionsDemonstrated ability to lead cross-functional teams,...RegulatoryFull timeFor contractorsLocal areaFlexible hours- Shionogi Inc. is seeking a Senior Manager/Associate Director of Regulatory Affairs CMC to define and execute global CMC regulatory strategies for... ...with a risk-based approach. Responsibilities include leading global CMC strategies, coordinating timelines, liaising with...Regulatory
- ...Florham Park, NJ, seeks a Senior Manager/Associate Director, Regulatory Affairs CMC to define global CMC regulatory strategies and deliver... ...compliance across the product lifecycle. Responsibilities include leading development of Global CMC regulatory strategies, managing...Regulatory
$145k - $165k
...value and cost-effective generic drugs in the United... ...About the Role The Regulatory Affairs Manager is responsible... ...of regulatory CMC strategies and submissions... ..., including complex sterile injectables and drug-device... ...as the Regulatory CMC lead for assigned development...RegulatoryFull timeFlexible hours- Merck & Co., Inc. in Rahway, NJ is seeking a Senior Scientist to lead Regulatory CMC for synthetic moieties in ADC programs, coordinating cross-functional teams to deliver regulatory milestones throughout development and lifecycle. The role requires a BS in science and...Regulatory
- Scorpion Therapeutics seeks an Associate Principal Scientist/Associate Director for Regulatory CMC focusing on biologics conjugates, ADCs, and bio‑conjugates. You will lead global regulatory strategies, prepare regulatory dossiers, and manage lifecycle changes for INDs...Regulatory
$173.2k - $272.6k
Job Description The Sterile Product Development group... ...including long-acting injectables (LAIs), across small molecules... ...dosage forms. Lead LAI formulation and delivery... ...Non-Clinical, Quality, Regulatory, Manufacturing, and... ...mitigation Contribute to CMC regulatory submissions...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Merck in Rahway, NJ seeks an experienced Regulatory Affairs professional to develop and implement... ...products. The role focuses on CMC dossiers, global submissions, and coordination... ...regulatory conformance. The candidate will lead documentation, authoring, and reviews for...Regulatory
$173.2k - $272.6k
...delivering a fully integrated stage-appropriate CMC development and commercialization... ...that may impact technical, operational & regulatory success or timelines. Analyzes and develops... ...impactful manner with proven ability to lead complex discussions, influence stakeholders...RegulatoryFull timeFor contractorsLocal areaFlexible hours$173.2k - $272.6k
...Principal Scientist role leading long-acting injectable formulation development across... ...with clinical, quality, regulatory, and manufacturing teams to... ...scientists Working knowledge of CMC regulatory expectations for... ...validation, and technology transfer for sterile injectables...Regulatory$90k - $125k
...value and cost-effective generic drugs in the United... ...About the Role The Regulatory Affairs Senior Associate... ...transdermal systems, injectables, drug-device... ...calls, as needed. Lead regulatory activities... ...cGMP requirements. ~ Sterile products experience...RegulatoryFull timeFlexible hours- ...Services, Inc is seeking a Senior Program Lead with deep Treasury, Cash Management,... ...role emphasizes business knowledge over generic program management. You will lead end-to-... ...define integration requirements, and ensure regulatory and customer needs are met within an enterprise...Regulatory
$98 - $100 per hour
...Global Regulatory CMC Manager Location: 50% onsite at Giralda Farms, NJ, 07940 Duration: 6 Months Hours: Mon-Fri 8am-5pm The GRS-CMC... ...responses and background packages (including participating / leading HA meetings with support); and/or post-approval submissions....RegulatoryHourly pay$173.2k - $272.6k
...Job Description The Sterile Product Development group... ...including long-acting injectables (LAIs), across small... ...parenteral dosage forms Lead LAI formulation and... ...Non-Clinical, Quality, Regulatory, Manufacturing, and Engineering... ...Contribute to CMC regulatory submissions...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...Director-level role leading the Development and Commercialization Team for biologics at Merck. Responsible for end-to-end CMC strategy execution, process development, regulatory filings, and commercial manufacturing readiness across multiple sites. Responsibilities...Regulatory- ImmunityBio in Summit, NJ, seeks a Principal Specialist, Health Authorities, to shape global regulatory strategy for investigational and marketed products. You will prepare, review, and finalize Health Authority submissions and responses, ensuring compliance with local...RegulatoryLocal area
- Scorpion Therapeutics in Summit, NJ is seeking a Team Lead for cryopreservation operations at a CAR T manufacturing facility. You will... ...include managing cryopreservation across shifts, ensuring regulatory adherence (FDA, cGMP, OSHA), reviewing batch records, and leading...RegulatoryShift work
- ...and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description• Assist and support regulatory CMC managers in the following activities:• Defining global CMC regulatory strategy and decisions for development projects or...RegulatoryImmediate start
$121.35k - $220.85k
...North American pharmaceutical injectables and non-injectable business.... ...trademark protection or clearance, regulatory approval, and launch. This... ...framework under which a generic manufacturer generates ANDA,... ...communication skills and ability to lead a must.Ability to work...Regulatory- ...Job title : Launch Acceleration and Regulatory Enablement Lead ~ Location: Morristown, NJ/Cambridge, MA About the job Innovation doesn... ...consistency of scientific and regulatory messaging across CMC, Clinical, Nonclinical, and Safety content. Support the...RegulatoryShift work
$18.5 - $23.5 per hour
...at the store to support accurate pricing of products. Ensures any additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the required time frame. Assist with bookkeeping activities, including...RegulatoryHourly payWork experience placementSeasonal workLocal areaShift work$173.2k - $272.6k
...Supply organization. Responsibilities: Lead Ignition and laboratory orchestration... ...Understanding of biologics, vaccine, sterile, small molecule, or analytical development... ...platform roadmaps. Strong understanding of regulatory, quality, and compliance considerations...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$156.9k - $247k
...initiatives, and contribute to capability roadmaps aligned with CMC needs.Talent development and MentorshipPartner with the... ...and external vendors to ensure reliable laboratory operations, regulatory compliance, and continuous capability advancement.External Scientific...RegulatoryFull timeFor contractorsLocal areaFlexible hours$108k - $176k
Manager, CMC Regulatory Affairs - BiologicsAt Regeneron, we use science and innovation to develop life-changing medicines for people with serious... ...portfolio in an on-site work model. In this role, you will lead regulatory strategy and regulatory compliance activities...RegulatoryFull timeWorldwide$180k - $270k
...medical needs. Kalaris’ lead asset, TH103, was... ...drug product. Oversee sterile fill-finish drug... ...production. Support IND/BLA regulatory submissions and... ...~ Expertise in sterile injectable biologics development and... ...analytical & formulation, CMC, and company meetings....RegulatoryNight shift- Role: Team Lead for cryopreservation operations at a CAR T manufacturing facility, responsible for overseeing the handling, storage... ...managing cryopreservation activities across shifts, maintaining regulatory adherence (FDA, cGMP, OSHA), overseeing documentation and batch...RegulatoryShift work
- Shionogi Inc. in Florham Park, NJ, seeks a Senior Manager, Regulatory Affairs CMC to lead strategy and coordination of CMC regulatory activities under the Senior Director, CMC. You will partner with R&D, QA, manufacturing, and regulatory authorities to ensure compliant...Regulatory
- Scorpion Therapeutics seeks a Senior Specialist Regulatory Pharmacologist - Promotions to oversee the review and approval of US promotional materials for immunotherapy and biologics products, shaping regulatory strategies and ensuring FDA compliance. You will manage FDA...Regulatory
- ...Pharmaceuticals USA Inc. seeks a Senior Marketing Specialist to support US Injectables marketing campaigns, ensuring timely development and delivery... ...channels. You will collaborate with Sales, Medical Affairs, Regulatory, and Legal to ensure accuracy, compliance, and brand...Regulatory
$127.28k - $190.92k
...the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient... ...as a project manager.Coordinate biologics CMC change control activities and related regulatory...Regulatory
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