Director of Regulatory Inspection Readiness
Celldex Therapeutics, Inc.
Celldex Therapeutics, Inc. seeks an experienced Director to lead the inspection management program, ensuring readiness for FDA/ international inspections and partner audits. You will coordinate across Quality, Manufacturing, Supply Chain, Regulatory Affairs, Clinical Development, and Commercial functions to support a transition to commercial readiness. The role requires a strong background in GMP compliance, regulatory inspections, and CAPA management, with global CMOs experience preferred. #J-18808-Ljbffr Celldex Therapeutics, Inc.
- Celldex in New Jersey is seeking a Director to serve as the primary architect and leader of the inspection management program, ensuring readiness for FDA inspections, partner audits, and... ...across Quality, Manufacturing, Regulatory Affairs, Clinical Development, and Commercial...Suggested
$225k - $275k
Sr Director of Regulatory Affairs - North America Location: Morristown, NJ, US, 07960 Description... ...risk management, and submission readiness, working in partnership with Category... ...cluster regulatory risk register Lead inspection readiness and regulatory response Primary...SuggestedWork at officeLocal areaRemote work2 days per week- ...program, quality agreements, vendor qualification activities and routine external audits. Drive inspection readiness and lead all internal/external audits, responses to regulatory inspections, partner audits and quality improvement initiatives. Quality Control...SuggestedContract workWork at officeRelocationFlexible hours
$176.4k - $327.6k
...Quality PlanEnsure adherence to global and local safety and regulatory internal and health authority standards, including GCP, GLP... ...ensure risks are detected and remediated, and submission/inspection readiness activitiesEstablish/ lead core governance for deviation/incident...SuggestedFull timeLocal areaRelocation package- ...Quality Management System (QMS), preparing for pre‑approval inspections, and supporting new product development. What You’ll Do... ...). Conduct internal audits and ensure inspection readiness (PAI, regulatory). Ensure compliance with cGMP and industry standards. Review...Suggested
$169.68k - $254.52k
...thinking, growing our capabilities and redefining ‘impossible’. Director, Regulatory Advertising and Promotion Purpose The Director, Regulatory... ...& Promotion colleagues to build a high‑performing, future‑ready team. Qualifications Required Qualifications Extensive knowledge...Work at officeLocal area$95k - $145k
...complex GxP systems as a Senior Consultant, Regulatory, Risk, and Compliance. This role supports system validation strategy, audit readiness, CAPA management, and risk-based... ...1, and data integrity expectationsDrive inspection readiness activities, including gap assessments...Remote workVisa sponsorship- Kite Pharma in the United States seeks a Director, Submission Project Management to lead... ...strategic and operational planning for major regulatory submissions (BLAs, sBLAs, NDAs) across... ...risks, and optimizes submission readiness while fostering organizational capability...
$115k - $125k
...through Friday, 8:30 AM - 5:00 PM Are you ready to work making the world a safer,... ...contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility... ...and regulatory expectations. Audits & Inspections Lead internal quality audits and inspection...Full timeContract workWork at officeLocal areaImmediate startWorldwideMonday to FridayFlexible hoursShift work$127.1k - $155.8k
...internal corporate procedures, and to all regulatory and statutory requirements through the... ...of experience with performing audits and inspections, supporting compliance with applicable... ...candidate for this or other roles! Are you ready to embark on a new journey? Join...Work at officeLocal area$106.79k - $189.5k
Regulatory Affairs Compliance ManagerPBF Energy Inc. (NYSE:PBF) is one of the largest independent refiners in North America, operating... ...mass balance, conversion factors, GHG calculations, and audit readiness and execution.PRINCIPAL RESPONSIBILITIES:Manage Compliance with...Full timeWork experience placement$108.5k - $201.5k
...processes evolve, and bring clarity to complex regulatory and audit landscapes. This role offers... ..., managing requests, documentation readiness, and stakeholder communicationsAssess and... ...and levels, including Associate Director and Director stakeholdersProven capability...Full time$250k - $280k
The Senior Director, Commercial Data Management and Strategy will... ...infrastructure in support of launch readiness, ongoing mergers, and long‑... ...be disclosed to applicable regulatory authorities, alliance... ...compliance with regulatory inspections and/or audits. EEO Shionogi...Full timeWork at officeLocal areaHome office3 days per week- ..., please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies...Full timeLocal areaWorldwide
- EPM Scientific in Morristown, New Jersey seeks a Director US Regulatory Lead to provide strategic regulatory leadership across a clinical-stage portfolio. You will lead preparation and lifecycle management of regulatory submissions, including labeling and promotional materials...
$140k - $200k
Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor responsible for defining... ...strategies and deliver scientifically sound, submission ready CMC content using a risk based approach. This individual...Full timeWork at officeLocal area$100k - $115k
...part of our continued success. The Sr. Director of Housing Operations, Compliance, and... ...affordable housing portfolio. This includes regulatory compliance across multiple federal and... ..., reporting requirements, inspections, and compliance calendars. Monitor regulatory...Permanent employmentFull timeWork at office$176.66k - $229.43k
...progress lifecycle opportunities by defining clear strategic intent, value hypotheses, and robust business cases from ideation to launch readiness. Lead the identification of key value drivers and translate these into the development of Target Product Profiles (TPPs), value...- Celldex Therapeutics, Inc. in the United States is seeking a Director, Lifecycle Management to shape strategic and commercial trajectory... ...own lifecycle opportunities from business case through launch readiness, collaborating across R&D, marketing and clinical development...
- Teva Pharmaceuticals is seeking a Director of Value & Access Strategy in Parsippany, New Jersey. In this role, you will lead the development of strategies to maximize patient access to Teva's Innovative Medicines, engaging with various stakeholders. You will cover pre-...
$203k - $267k
.... Join the team in making better possible for patients everywhere. Summary This role directs, manages, evaluates and implements regulatory projects in support of company goals in the area of clinical strategy. The position will play a major role in shaping cohesive regulatory...For contractorsLocal areaFlexible hours$127.5k - $184.17k
...real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As an US Regulatory Affairs Senior Manager - Allergy, you’ll bring your skill, your curiosity and your drive to make health simpler...Worldwide- Bayer CropScience Limited is seeking a Director of Regulatory Advertising and Promotion to lead strategic regulatory efforts in compliance with U.S. regulations. The ideal candidate will have extensive FDA knowledge, significant experience in promotional submissions, and...
- ...require some travel as business needs dictate. Summary of Position: This individual will be responsible for providing strategic regulatory advice and oversight for all of Altimmune's US regulatory applications, including the preparation and management of relevant...Local areaRemote work
$215k - $250k
...meet FDA standards while advancing business goals. Your Role The Director, US Reguatory Advertising and Promotion oversees and guides... ...advertising and promotional materials, ensuring they meet U.S. regulatory standards while supporting clear, truthful, and compliant...Permanent employmentContract workWork at office$199.95k - $242.3k
## Director, Regulatory CMC - Cell TherapyMadison - Giralda - NJ - USFind out how well you match with this job**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Leo Pharma GmbH seeks a Director of US Regulatory Advertising & Promotion to lead regulatory strategy for advertising and promotion. The hybrid role is based in Madison, NJ, requiring oversight of materials to ensure US compliance and alignment with brand objectives. The...
- Teva Pharmaceuticals is seeking a Director, REMS Operations in Parsippany, NJ. This role involves developing and implementing Risk Management Programs, ensuring compliance with FDA regulations, and managing a team of 3. The ideal candidate will have significant experience...
$90k - $200k
...a broad range of complex investigations, forensic accounting, regulatory compliance, including business intelligence, internal (client)... ...empowering environment, propelling your career to new heights. Ready to build, protect, restore and maximize our clients' value? Your...Temporary work$120k - $150k
...) plays a critical role in ensuring the quality, safety, and regulatory compliance of sterile pharmaceutical products manufactured by... ...to support product registrations, submissions, and regulatory inspections related to third-party manufacturing. Assists in drafting...Full timeWork at officeLocal area
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