Director, Global Labeling Regulatory
Scorpion Therapeutics
Position Summary: Director, Global Labeling Regulatory orchestrates global development, maintenance, and compliance of product labeling throughout a drug's lifecycle; manages direct reports and partners cross-functionally to ensure investigational/marketed drug labeling meets global health authority requirements. Essential Functions / Responsibilities: Manage creation/execution of global labeling strategies from early clinical through commercialization. Lead day-to-day team activities (hire/train, coach, monitor performance). Prepare/maintain key labeling documents (USPI, EU SmPC). Ensure labeling content/artwork complies with health authority regulations and GMP (monitor changes and implement updates). Manage updates to label content/artwork for packaging/supplies with manufacturing and third-party vendors. Review/approve label proofs from internal/external teams. Oversee/advise label content negotiations with Regulatory Agencies. Draft/lead responses to health authority comments/questions on labeling issues. Collaborate on global labeling/CMC matters; manage labeling change controls. Oversee/draft label technical specifications; may train Regulatory Affairs SOPs/templates. Perform ad-hoc/cross-functional projects as needed. Education & Experience (Required/Preferred): Bachelor’s (14+ years) or Master’s (12+ years) in life sciences/technical discipline. Required: extensive Global Health Authority regulatory labeling experience (clinical + commercial). Plus: eCTD CMC module preparation/submission. Preferred: managing staff; Veeva Vault. Skills/Knowledge: Biologic-based drug labeling expertise (cell/gene therapies, antibodies, recombinant proteins). Leadership, complex matrix experience, deadline management. Electronic document management proficiency; strong communication/organization; cultural sensitivity. Benefits (as stated): Medical/Dental/Vision wellness programs EAP life/AD&D short/long-term disability FSAs 401(k) match 529 PTO/holidays #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Director, Global Labeling Regulatory in Summit, NJ vacancy
- Scorpion Therapeutics seeks a Director, Global Labeling Regulatory to steer global labeling strategy from early clinical through commercialization. You will lead a cross-functional team, ensure USPI/EU SmPC alignment, and supervise labeling content with manufacturing and...Regulatory
$178.5k - $257.83k
...Job title : Director, US Advertising and Promotion, Global Regulatory Affairs ~ Location: Morristown, NJ or Cambridge, MA About the job: As... ...Advertising and Promotion (A&P) group on promotion, labeling, product defense, and development strategies for...RegulatoryFull time$168.1k - $268.7k
...As an Associate Director in Regulatory Affairs, Advertising and Promotion at BioNTech, you will... ...developing innovative therapies that improve global health. You’ll lead interactions with... ...(OPDP) and Advertising and Promotion Labeling Branch (APLB), ensuring alignment with...RegulatoryHourly payWork at office$129k - $203.1k
...seeking a dynamic and experienced leader to join our Global Pharmacovigilance (GPV) team as an Associate Director. In this critical role, you will lead a dedicated... ...team meetingsSupport and participate in regulatory audits and inspections, including readiness preparation...RegulatoryFull timeFor contractorsLocal areaFlexible hours$198k - $264k
...AI with confidence. Trusted by leading AI labs, startups, and global enterprises, CoreWeave combines superior infrastructure performance... ...(Taiwan, Japan, South Korea, China) and navigating associated regulatory and logistics considerations Background in contract negotiation...RegulatoryPermanent employmentContract workTemporary workCasual workWork at officeFlexible hoursCoreWeave
Livingston, NJ3 days ago- DSV - Global Transport and LogisticsAt DSV, our purpose is to keep customers’ supply chains flowing and enable the business of our customers... ...global supply chains, production and aftermarket requirements, regulatory and security considerations, technological advancement,...RegulatoryFor contractorsLocal areaWorldwide
- Lonza Group Ltd. seeks an experienced Director, Sterility Assurance to lead global sterility and contamination control across its sterile manufacturing... ...operations. The position oversees risk assessments, CAPAs, regulatory readiness, and cross-site harmonization while acting...Regulatory
$129k - $203.1k
Job DescriptionThe role of Associate Director, Global Oncology Communications, is a unique opportunity to join our company, a recognized... ...communications (data releases, medical meeting communications) and regulatory milestones and approvals.Drive integrated editorial strategy...RegulatoryFull timeTemporary workFor contractorsWork at officeLocal areaRemote workWorldwideFlexible hours$142.4k - $224.1k
...DescriptionThis is a pivotal moment to join the Global Infectious Diseases Team as a... ...Infectious Diseases portfolio.As an Associate Director on the Global Commercial Team, you will... ...Marketing, Medical, Market Access, Regulatory, Supply, and other key functions. Influence...RegulatoryFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$140k - $198.45k
Associate Director, Global Product MarketingLocation: Morristown, NJJoin Lonza's Capsugel Dosage Forms Solutions (DFS) business and help... ...with Product Management, Commercial Development, Sales, R&D, Regulatory Affairs, Supply Chain, and regional marketing teams to translate...RegulatoryFull timeTemporary workRemote work3 days per week$121k - $220k
Job Title: Director, North America Medical AffairsLocation: Berkeley Heights NJ or Columbus... ...strategic bridge between Hikma’s R&D, Regulatory Affairs, Pharmacovigilance (PV), Quality... ...FTEs or contracted writers and agencies4.6 Labelling, Prescribing Information, and Package...RegulatoryFor contractorsWorldwide$300k - $350k
...what we can achieve. Together.SummaryThe Director, Tax, working in collaboration with and... ...responsible for leading the firm’s domestic and global tax strategy, compliance, planning,... ...on tax matters, including tax strategy, regulatory developments, partner-related tax...RegulatoryFull timeWork at officeLocal areaRemote workRelocationVisa sponsorshipRelocation package$183.1k - $305.2k
...Director, Pharmacovigilance Hub At Regeneron, we use science and... ...Pharmacovigilance Hub to join our Global Patient Safety Operations... ...with global standards, local regulatory requirements are met, and all... ..., safety communications, labeling updates, and local submission...RegulatoryWork at officeLocal areaWorldwideRegeneron
Warren, NJ1 day ago$160k - $210k
...& Purpose Of The PositionThe Associate Director, Field Medical Training, Insights & Analytics... ..., including management of legal, regulatory & medical approval process of various training... .... Collection of best practices from global colleagues, and US franchises are also in...RegulatoryTemporary workLocal areaFlexible hours$129k - $203.1k
Job DescriptionJob Description:The Global Clinical Supply (GCS) organization manages the... ...accountable for the planning, sourcing, labeling, packaging and delivery of clinical... ...and supply chain processes with relevant regulatory and GMP requirements.Ability to establish...RegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours- ...dynamic and strategic Medical Director to lead Medical Affairs... ...Leadership Develop and execute the global Medical Affairs strategy... ...shaping efforts. Partner with Regulatory, Market Access, Program Lead,... ...evidence generation strategies, labeling considerations, and payer‑relevant...RegulatoryWork at officeLocal area2 days per week
Altimmune, Inc.
Convent Station, NJ5 days ago $226.19k - $292.71k
...Director of Biostatistics at Gilead At Gilead, we're creating a... ...collaboratively for the development plans, regulatory interactions, and commercial... ..., Clinical Data Management, Global Drug Safety, Regulatory and... ...in NDA/BLA filing through label negotiation Effective...RegulatoryFor contractorsLocal areaGILEAD
Parsippany, NJ5 days ago$185k - $230k
...impactful role, you'll partner across medical, commercial, regulatory, and global teams to advance scientific excellence and bring meaningful... ...living with rare skin diseases.Your Role:The Associate Medical Director is responsible for the development of medical strategy for...RegulatoryPermanent employmentContract workWork at office- ...difference. Position Summary Director of Biostatistics is a member of cross-... ...study objectives that will support regulatory approval and market access. Contributes... ...with BMS processes and SOPs, adherence to global and project standards within an indication...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work
Bristol-Myers Squibb
Madison, NJ1 day ago $244.56k - $296.35k
...the careers of those who do it. Senior Director, Biospecimen Management About the Role... ...& Imaging (CBI) organization within Global Development Operations, designed to drive... ...during internal audits and vendor visits Regulatory & Scientific Expertise Maintain...RegulatoryHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours- ...risks to patient safety to present to senior management and regulatory authorities globally. Responsibilities Responsible for standard surveillance... ...inform on necessary risk minimization activities, including label changes. Collaborative preparation and maintenance of...RegulatoryWork experience placementLocal area
BioSpace, Inc.
Florham Park, NJ1 day ago $129k - $203.1k
...of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to... ...resolution of issues in the following areas:Clinical Packaging and Labelling,Distribution of clinical supplies andDispositioning...RegulatoryFull timeFor contractorsLocal areaFlexible hours- ...Blue Owl Capital Inc. is seeking a Managing Director, Americas' Distribution and Global Marketing to lead the firm's broker-dealer and marketing compliance... ...You will partner with senior stakeholders to ensure regulatory alignment and risk management for distribution...Regulatory
- ...where you’ll be part of a collaborative global team. Embracing our cultural diversity,... ...Description Position Summary The Global Director, Strategic Sourcing – Personal Care is... ..., Operations, Quality, Finance, Regulatory, Procurement Operations, and regional teams...RegulatoryContract workWork at officeWorldwide
$209.25k - $253.57k
...Associate Director, Clinical PharmacologyWorking with Us Challenging. Meaningful. Life-changing... ...-functional drug development teams, regulatory submissions, and departmental... ...bereavement, and military needs and an annual Global Shutdown between Christmas and New Years...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeRemote workFlexible hoursShift workBristol-Myers Squibb
Madison, NJ5 days ago$136.5k - $200k
...Position Overview Tonix is looking for a full-time Associate Director, Regulatory Affairs to effectively develop regulatory strategies and... ...phase interactions with regulatory authorities (FDA and/or global), providing direction and actively participating in overall...RegulatoryFull timeTemporary workWork at officeLocal areaRemote workFlexible hoursTonix Pharmaceuticals
Berkeley Heights, NJ3 days ago- ...Job ID: 4851 Role DescriptionAssociate Director - Supply Chain - Pharma Commercial - USRoles... ...and shipments with production sites and global distribution, ensuring valid and timely... ...Supply Chain, distributors, Commercial, Regulatory, Quality, Serialization, and HQ.Risk...RegulatoryPermanent employmentContract workShift work
- ...KPMG is currently seeking an Associate Director, Presales Solution Architect - KYC/AML to... ...close collaboration with Member Firms and Global/Regional Risk leadership Act with... ...managed services Strong background in regulatory interpretation and impact assessment across...RegulatoryH1bLocal area
KPMG
Short Hills, NJ4 days ago - Bristol-Myers Squibb in Summit, NJ is seeking a Manager, Label Operations to oversee label management within the S12 Cell Therapy manufacturing... ...will lead the Label Operations team, ensuring compliance with regulatory standards and efficient label issuance processes. The ideal...Regulatory
$140k - $200k
Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on... ...for defining and executing global CMC regulatory strategies for assigned... ...development plans, control strategies, labeling content, and Health Authority responses...RegulatoryFull timeWork at officeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Global Labeling Regulatory. Be the first to apply!
