Senior Director, Medical Affairs CSLSenior Director, Medical AffairsKing of Prussia, PAThe Senior Director, Medical Affairs, Hematology Pipeline is a senior-level global leadership role responsible for architecting and executing the end-to-end Medical Affairs pre-launch and peri-launch strategy for a high-priority hematology asset. This role serves as the primary Medical Affairs point of accountability for pipeline readiness, leading a team of four direct reports across US and International regions and collaborating extensively with cross-functional enterprise partners.
NewSenior Manager, Clinical Quality Larimar TherapeuticsSenior Manager, Clinical QualityPhiladelphia, PAPosition Overview: The Senior Manager, Clinical Quality serves as the study-level quality leader for the clinical quality assurance program for a clinical-stage biotechnology company focused on developing innovative therapies for patients with rare diseases through novel cell-penetrating peptide technology. This highly visible, cross-functional role partners with Clinical Operations, TMF Management, Biostatistics, Data Management, Medical Affairs, and external service providers to ensure the quality and integrity of clinical trial activities throughout the product development lifecycle.
NewManager, Drug Product Manufacturing Larimar TherapeuticsManager, Drug Product ManufacturingPhiladelphia, PAThe successful candidate will provide technical leadership across drug product manufacturing, process validation, lifecycle management, and commercialization efforts while partnering closely with Technical Operations, MSAT, Quality, Regulatory Affairs, Supply Chain, Process Development, and external partners. Reporting to the Head of Drug Product, CMC Technical Operations, the Manager/Senior Manager, Drug Product Manufacturing is responsible for overseeing external manufacturing operations and technology transfer activities for lyophilized biologic drug products supporting clinical and commercial supply.
NewAssociate Director, Quality (Validation and Data Integrity) Larimar TherapeuticsAssociate Director, Quality (Validation and Data Integrity)Philadelphia, PAThe responsibilities for the Associate Director/Director, Quality, Validation and Data Integrity may include, but are not limited to the following activities: Provide Quality oversight of Computer System Validation (CSV)/Computer Software Assurance (CSA) activities related to initial implementations, changes, periodic review, maintenance, and decommissioning of GxP systems. The management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and the development of manufacturing processes utilizing good manufacturing practices (GMPs).
NewDirector of Strategy & Impact (Grants & Allocations) Jewish Federation of Greater PhiladelphiaDirector of Strategy & Impact (Grants & Allocations)Philadelphia, PAServe as primary liaison between S&I and other departments on all workflows, including but not limited to: FRD and S&I departments for grantmaking committees (JFRE, Weinberg, WOV) and philanthropic guidance for restricted gifts, including identifying funder priorities and community needs. Work with Chief Strategy & Impact Officer on strategic planning for the Strategy & Impact department, including working with the Director of Israel and Global Operations to align funding priorities, budget operations, and missions and lay leader travel, and restricted gift workflow.
NewAssociate Director, Global Knowledge Management CSLAssociate Director, Global Knowledge ManagementKing of Prussia, PAWith a focus on leadership and innovation, this role is responsible for the overall administration, organization, governance, strategic planning, budget administration, and personnel management of the Global Knowledge Management (GKM) team. Drives vendor relationship management and procurement decisions for key knowledge resources, databases and APIs ensuring strategic alignment and cost efficiency.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineUpper Gwynedd, PA$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Associate Director, Promotional Regulatory Affairs AstraZeneca PlcAssociate Director, Promotional Regulatory AffairsWilmington, DE$150,098–$225,147 / yearAs the Associate Director Promotional Regulatory Affairs, you will ensure efficient and effective regulatory review and risk assessment of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic), sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and any other materials required to be reviewed through AZAP. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products in the US.
Associate Director, Commercial Regulatory Affairs Bristol-Myers Squibb CoAssociate Director, Commercial Regulatory AffairsPrinceton, NJ$173,350–$210,058 / yearResponsibilities include: Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area. Description: The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyCollegeville, PA$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
Regulatory Affairs Specialist, Global Quaker HoughtonRegulatory Affairs Specialist, GlobalConshohocken, PASupport chemical regulatory activities related to documentation including updating raw material information, communicating changes to raw material classifications, data management and updating the SDS system. Supports the Product Stewardship organization globally with responses to key stakeholders including regulatory inquiries, SDS authoring, and answering regulatory inquiries.
Associate Director, Regulatory Affairs Project Planning & Coordination ACADIA Pharmaceuticals Inc.Associate Director, Regulatory Affairs Project Planning & CoordinationPrinceton, NJ$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
Executive Director, Regulatory Affairs Liaison Merck & Co IncExecutive Director, Regulatory Affairs LiaisonNorth Wales, PA$231,900–$365,000 / yearRequired Skills: Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}. Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.
Director, Global Regulatory Affairs Lead (Oncology) GSK plcDirector, Global Regulatory Affairs Lead (Oncology)Collegeville, PA$171,750–$286,250 / yearProven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions. Works with the respective GRS TG Portfolio Lead and TG VP to ensure a robust regulatory strategy and appropriate TG resource is in place to support respective development programs to meet the needs of the key markets identified in the IES and the Medicine Profile.
Director/Sr. Director/Executive Director, Clinical Regulatory Affairs SystimmuneDirector/Sr. Director/Executive Director, Clinical Regulatory AffairsPrinceton, NJ$200,000–$300,000 / yearThe Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development teams and the RA Department in all aspects of global regulatory affairs related to development of novel oncology therapeutics (multiple modalities such as ADCs, bispecific antibodies and T-cell engagers etc.). Own/drive the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure.
Senior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies IncSenior Director, Regulatory Affairs (Ad Promo)Philadelphia, PA$215,000–$296,000 / yearRepresents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo. Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA.
Director/Sr. Director/Executive Director, Clinical Regulatory Affairs SystImmune, Inc.Director/Sr. Director/Executive Director, Clinical Regulatory AffairsPrinceton, NJ$200,000–$300,000 / yearThe Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development teams and the RA Department in all aspects of global regulatory affairs related to development of novel oncology therapeutics (multiple modalities such as ADCs, bispecific antibodies and T-cell engagers etc.). Own/drive the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure.
Manager, Product Stewardship & Regulatory Affairs AzelisManager, Product Stewardship & Regulatory AffairsWest Chester, PennsylvaniaTeamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Regulatory & Clinical Affairs Manager PEAK Technical StaffingRegulatory & Clinical Affairs ManagerPrinceton, NJCandidate Privacy To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/and https://peaktechnical.com/ca-residents-privacy-rights/ This individual will prepare and execute FDA, EU MDR, and international regulatory submissions while partnering closely with engineering, quality, and clinical teams throughout product development.
NewSenior Director, Regulatory Affairs Immunocore Holdings PlcSenior Director, Regulatory AffairsRadnor, PA$250,000–$270,000 / yearVacancy NameSenior Director, Regulatory Affairs Vacancy NoVN870 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA DepartmentRegulatory Affairs Key ResponsibilitiesThe Senior Director of Regulatory Affairs will be responsible for assigned projects and all of the regulatory affairs activities by providing expertise to Immunocore's development programs to include regulatory scientific and tactical strategy development, IND development/submission/maintenance, BLA/sBLA development/submission/maintenance, agency liaison and regulatory intelligence. $250,000- $270,000 About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease.