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
$142.4k - $224.1k
Job DescriptionAssociate Principal Scientist, Regulatory CMC Digital InnovationRahway, NJ or West Point, PAOur Company is a global health... ...industry, with a strong background in Regulatory CMC, Regulatory Affairs, or related pharmaceutical technical operations.Hands-on...SuggestedFull timeFor contractorsSummer internshipLocal area$117k - $201.25k
...Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/TechnologyAll Job Posting... ...talent for Principal Scientist (Manager), Global Regulatory Affairs, CMC.Purpose: The Principal Scientist of Global Regulatory Affairs...SuggestedFull timeLocal areaImmediate start- Position PurposePartnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global Operations stakeholders, to... ...challenges and deliver innovative, timely regulatory CMC solutions that meet evolving regulatory and compliance requirements...SuggestedFull timeFlexible hours
- 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
- Merck, with locations in Rahway, NJ or West Point, PA, seeks Associate Principal Scientist, Regulatory CMC Digital Innovation to lead AI-enabled regulatory authoring and digital solutions across CMC workflows. This role partners with Regulatory CMC, GRACS and R&D to accelerate...Suggested
- Johnson & Johnson Innovative Medicine is seeking a Principal Scientist (Manager) for Global Regulatory Affairs, CMC, to drive global regulatory strategies for large molecules, vaccines, and delivery devices. You will lead CMC submissions and align with GRA leadership across...
$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- Johnson & Johnson Horsham site seeks a Principal Scientist (Manager) for Global Regulatory Affairs, CMC. You will develop global CMC strategies, lead regulatory dossiers, and provide direction on large molecule programs across markets. Responsibilities include leading CMC...
$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- Johnson & Johnson Innovative Medicine is seeking a Principal Scientist (Manager) in Global Regulatory Affairs, CMC, to lead global regulatory strategies for large molecules and drive regulatory submissions across markets. The role partners with CMC teams to ensure lifecycle...
- ...-3 times onsite per week) ASAP start The Regulatory Program Manager (RPM) will be an asset-level... ...) and partners across Global Regulatory Affairs as well as Project Management, Medical... ...whose experience is limited strictly to the CMC (Chemistry, Manufacturing, and Controls)...Contract workImmediate startWorldwideFlexible hours
$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:Horsham, Pennsylvania, United...Full timeWork experience placementLocal areaImmediate startWorldwide- ...Regulatory Affairs Manager Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996,...Temporary workWorldwide
Integrated Resources
Spring House, PA5 days ago $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- ...quality related qualification a plus. Qualification/Experience A minimum of 5 years + of professional experience in compliance, regulatory affairs, or a related field. Extensive knowledge and understanding of relevant regulations and compliance concepts relevant to the...
AA2IT
Lansdale, PA4 hours 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- ...Senior Director, Regulatory Affairs ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and...
ICON
Blue Bell, PA1 day ago - ...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...
- ...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.
$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$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- ...Regulatory Program Manager Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected... ...& FTEs) SCHEDULE MANAGEMENT: ~ Owns the Global Regulatory Affairs (GRA) schedule in P5; creation, monitoring and maintenance....Temporary workWorldwide
Integrated Resources
Spring House, PA5 days ago - ...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
- .... • The person will be responsible for regulatory change management activities as a Site Compliance... ...closure of the deficiency letters and CMC Commitments, Regulatory requests for... ...Controls (GCMC) department or Local Regulatory Affairs (for Single market products) for the...Contract workFor contractorsLocal areaFlexible hours
Integrated Resources
Collegeville, PA4 days ago - 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...
$137k - $235.75k
...Senior Manager, North America Regulatory Liaison At Johnson & Johnson, we believe health is everything. Our strength in healthcare... ...Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development,...Local areaImmediate start- ...TRUMARK CREDIT UNION Job Title: Regulatory Compliance Analyst Department: Compliance Location: 335 Commerce Dr, Fort Washington, PA 19034 Employment Type: Full-Time Join Our Team and Make a Difference Looking for a workplace that values your growth...Full time
TruMark Financial
Fort Washington, PA23 hours ago - ...CPGs, emerging brands. Overview Establish and maintain clients regulatory operations program, including establishment of procedures for... ...Certification such as Certified Quality Auditor or Regulatory Affairs Certificate preferred Knowledge of relevant GMP regulations:...Permanent employmentContract workLocal area
$1,000 per month
...the Company’s compliance risk assessments and development of compliance test plans.Serve as a Company’s subject matter expert on regulatory disclosure requirements, ensuring that the Company complies with all federal, state, and local disclosure requirements.Serve as the...Full timeLocal area- ...and outcomes of surgery so patients can resume their lives as quickly as possible. Position Summary : The Manager, Regulatory Affairs, is responsible for preparing, filing and gaining approval of 510(k), IDE, and PMA submissions to the U.S. Food and Drug Administration...Full time
Globus Medical
Norristown, PA3 days ago
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