- Merck & Co. (Upper Gwynedd, PA)
- …with risk mitigation measures.-Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical ... Regulatory Affairs Operations with Labeling Process and/or Digital Enablement...soon as possible.Job Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...& variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Merck & Co. (Rahway, NJ)
- …Areas, Portfolio Management, Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, ... operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of… more
- Eisai, Inc (Exton, PA)
- …technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls( Associate Director Equivalent) Our company's Device Development & ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site ... Alameda, CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine… more
- Kyowa Kirin North America (Princeton, NJ)
- …with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs, Advertising and Promotion ... with US regulatory requirements. In addition, the associate director will be responsible for supporting...and the ability to interact effectively with cross functional project teams. Working Conditions: Requires up to 10% domestic… more
- Merck & Co. (Durham, NC)
- …Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and ... in alignment with overall business objectives. Relationships Reports to the Sr. Director , Wegovy Consumer Marketing . C ollaborates with sales, marketing, training,… more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …market that are making a real impact on patient outcomes. Job Summary: The Associate Director of Post-Marketing is responsible for providing management of a ... post-marketing regulatory activities, ensuring compliance with regulatory requirements,...be asked to be a department representative on selected project teams for commercial products, for completion of post-marketing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Merck & Co. (North Wales, PA)
- …team. You will build and coach your team in the development of project management, communication, and collaboration skills in support of our clinical trials.Job ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Merck & Co. (Rahway, NJ)
- …areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Exposure to project / engineering ... of the Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to… more
- Clinical Dynamix, Inc. (Waltham, MA)
- …to the Sr. Director , Clinical Excellence Operations the Senior Manager/ Associate Director , Records Management will be responsible for expertise, oversight, ... management activities across all therapeutic areas of development at Company. The Associate Director of Records Management will provide direct management and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Invivyd (New Haven, CT)
- …part of making a difference. Be part of Invivyd. Job Title: Senior Manager/ Associate Director , Drug Safety and Pharmacovigilance Operations Position summary: The ... Sr. Manager/ Associate , Drug Safety and Pharmacovigilance Operations encompasses a key...and Safety Data Exchange Agreements. Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current… more
- Los Angeles Metro (Los Angeles, CA)
- …Metro functional units for successful execution. This position will provide project management for Communications related capital projects including planning, scope ... development, project schedules, reporting, coordinating and working with consultants and...major public works projects Applicable federal, state, and local regulatory requirements and standards Projection techniques for determining staffing… more
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