Assoc. Dir, Regulatory Affairs-CMC
Scorpion Therapeutics
Responsibilities Drive AI-enabled regulatory authoring capabilities (incl. Module 2/3), develop job aids, and identify generative AI drafting opportunities. Monitor emerging AI/digital technologies and assess utility for Regulatory CMC processes. Lead cross-functional work for AI authoring, process automation, regulatory intelligence, and digital transformation. Establish and embed a CMC digital/AI operating model aligning localized AI efforts with enterprise digital strategies. Coordinate with Regulatory CMC Systems/Operations on digital solutions affecting regulatory platforms (e.g., Veeva). Serve as primary point of contact for key digital tools/platforms (e.g., ERA App) and support CMC digital tracking/reporting. Partner with R&D and Manufacturing to identify shared digital opportunities and ensure data/process handoffs. Champion enterprise AI adoption via networks (e.g., AI Pioneers Champions Network), feedback loops, and change management/training. Propose/lead/mentor digital project teams, including GRACS CMC summer intern projects. Education Minimum BS or equivalent in a Scientific/Technical/Regulatory field (chemistry, biology, pharmacy, computer science, or data analytics preferred). Required Experience 5+ years in pharma/biotech with strong Regulatory CMC/Regulatory Affairs background. Hands-on experience building/optimizing regulated digital tools and modern AI/LLM solutions. Enterprise solution delivery experience improving business outcomes. Technical change management (repeatability assessments, job aids, end-user training). Mentoring/coaching on digital projects/workflows; strong matrix collaboration and communication; project coordination. Up to 10% travel. Required Skills Change management, collaboration, eCTD, emerging technologies, stakeholder partnerships, regulatory CMC/compliance/documents/strategy/submissions/reporting, project leadership, regulatory documents. Benefits Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days. #J-18808-Ljbffr Scorpion Therapeutics
$173.2k - $272.6k
Position Summary The Director, CMC Operations Content Management and Digital Enablement will serve as a leader and subject matter... ...and document standards. This role will partner closely with Regulatory Affairs, CMC, Quality, IT, and global business stakeholders to define...SuggestedFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Merck & Co. is seeking a Director, CMC Operations Content Management and Digital Enablement to lead global content management across the lifecycle, partnering with Regulatory Affairs, CMC, Quality, IT, and stakeholders to define strategy and governance. The role emphasizes...Suggested
$258.83k - $293.48k
...strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.The Senior Director of Regulatory Affairs CMC provides highly strategic, tactical and operational regulatory CMC leadership to support clinical trial applications,...SuggestedMinimum wageFull timeWork at officeLocal areaFlexible hours3 days per week- Scorpion Therapeutics seeks a senior candidate to lead AI-enabled regulatory CMC initiatives in a fast-paced biotech environment. You will drive AI drafting, digital tooling adoption, and cross-functional collaboration to modernize regulatory submissions. You will mentor...Suggested
$109k - $174.8k
...& Pre-Clinical/Clinical Development Job Sub Function: Regulatory Science Job Category: Scientific/Technology All Job Posting... ...R&D is recruiting for a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities. This position is a hybrid role...SuggestedFull timeLocal areaImmediate start- Regulatory Project Manager, Strategy - CMC RA Small Molecules Mature Products Business At GSK, we have bold ambitions for patients, aiming to positively... .... Minimum of 2 years’ experience in CMC regulatory affairs focused on small molecules, including lifecycle management...Local area
$117k - $184.2k
...Job Description SENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATES Position Description: Serve as... ...Ligand Binding, Pharmaceutics, Process Chemistry, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory...Full timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Merck seeks a Director of CMC Operations Content Management and Digital Enablement to lead global regulatory content, governance, and digital enablement for chemistry, manufacturing... ...lifecycle. You will partner with Regulatory Affairs, CMC, Quality, IT, and stakeholders to...
$117k - $201.25k
...Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/TechnologyAll Job Posting... ...Medicine R&D is recruiting for a Principal Scientist, CMC Regulatory Affairs - Combination Products. This position is a hybrid role and...Full timeLocal areaImmediate start- CSL Behring is seeking a senior Regulatory Affairs CMC professional to shape enterprise-wide regulatory strategies for biologics and plasma products. The role collaborates with Global Regulatory Affairs, R&D, Quality, and Global Operations to ensure compliant, timely submissions...
- GSK is seeking a Regulatory Project Manager, Strategy to provide CMC regulatory support for a portfolio of small‑molecule products across global markets. The role offers exposure to lifecycle management and regulatory strategy, with visible influence on product life cycles...
- Scorpion Therapeutics is seeking a Senior Scientist Product Lead in CMC Regulatory Affairs, focusing on synthetics and new modalities. You will drive global regulatory strategies and dossier development for innovative medicines in a senior capacity. The role emphasizes...
$137k - $235.75k
...individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category:ProfessionalAll Job Posting Locations:Raritan, New Jersey, United...Full timeLocal areaImmediate startFlexible hours$150k - $258.75k
...compliance leader responsible for translating emerging and evolving regulatory expectations into practical, science- and risk-based, and... ...of Quality, Manufacturing, MSAT, Engineering, Regulatory Affairs, Product Development, Supply Chain, Digital, and Technical Operations...Local areaImmediate start- Role: Senior Scientist Product Lead in CMC Regulatory Affairs specializing in Synthetics and New Modalities, supporting global regulatory strategies and dossier development for innovative medicines. Responsibilities: develop and implement CMC regulatory plans for development...
$129k - $153k
...meaningful difference worldwide.Position Overview: Regulatory leaders who leverage regional regulatory... ...partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure ‘One GRA Voice’,...Full timeWorldwideRelocation package- Job Title: Director, Regulatory Affairs, Pharmaceuticals Employment Type: Permanent Location: 300 Welsh Road, Building 5, Suite 201, Horsham,... ...Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations. Must...Permanent employment
- ...vendor oversight activities for assigned trials / indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. Monitors risks and mitigation during study...
- ...pharmaceutical products. Responsibilities: Leading target labeling development, collaborating with cross-functional teams (clinical, safety, regulatory, commercial), and aligning labeling strategies with global regulatory and product plans. Analyzing competitor labeling, guiding...Local areaWorldwide
- ...vendor oversight, requiring strong skills in project management, collaboration, and quality assurance. Applicants should have solid experience in regulatory compliance and the ability to monitor clinical trial execution effectively. #J-18808-Ljbffr Integrated Resources Inc.
- Merck & Co. is seeking a CIPM Associate Director, Project Manager to lead end-to-end CMC development efforts, coordinating cross-functional teams from First in Human to Transfer to Supply. Based in the US, candidates will drive portfolio integration and governance while...
$137k - $235.75k
...individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category:ProfessionalAll Job Posting Locations:Raritan, New Jersey, United...Full timeLocal areaImmediate start- Dir Operations Chronic page is loaded## Dir Operations Chronicremote type: Onsitelocations: Willow Grove, PAtime type: Full timeposted... ...assigned area ensuring compliance with established company and regulatory guidelines and procedures in order to provide high quality...Local area
$142.4k - $224.1k
...company, driving these cross-functional teams to deliver projects and products that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to enhance our Project & Portfolio management functions which support...For contractorsRelocationVisa sponsorshipFlexible hoursShift work$231.9k - $365k
Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to...Full timeFor contractorsLocal areaWorldwideFlexible hours$100k - $120k
...technological advancement and process improvement. Position Summary We are seeking an Compliance Manager to support the company’s regulatory compliance program, ensuring manufacturing, distribution, and business operations comply with all applicable laws and regulations...Full timeFor contractorsLocal areaShift workGeissele Automatics
North Wales, PA3 days ago$1,000 per month
...solutions and recognizing great performance.Primary FunctionThe Regulatory Correspondence Specialist III is accountable for handling... ...year of Mortgage Servicing experience.Experience in Regulatory Affairs and/or Quality Assurance in mortgage servicing, previous complaint...Full timeWork at officeLocal area- Scientific Search is seeking a Regulatory Affairs professional to establish and maintain regulatory operations for cosmetics, OTC pharma, and medical device products under MoCRA. You will ensure current FDA registrations and listings, monitor regulatory changes, and manage...
- ...primary and derived labeling documents, and text for artwork for packaging components (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling documents) • Contribution to and implementation of the global...Work at officeImmediate startFlexible hours
- ...Purpose Partnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global Operations stakeholders, to... ...strategy challenges and deliver innovative, timely regulatory CMC solutions that meet evolving regulatory and compliance requirements...Flexible hours
CSL
King of Prussia, PA1 day ago
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