alternative resources company Jobs

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Assoc. Director\Director Regulatory Affairs Advertising & Promotion

Alternative Resources Company - Somers, NY

This position within the Regulatory Affairs department involves the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulation/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). Will ensure that messages are translated into ad...

Application Deadline: None

Executive Director, CMC Regulatory Affairs

Alternative Resources Company - Somers, NY

Will supervise/lead/mentor regulatory CMC personnel so that all corporate objectives are met within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. In addition the position assists Industrial Operations Product Supply (IOPS) senior management in developing strategies/processes to meet corporate objectives.

Application Deadline: None

Principle\Manager Biostatistician

Alternative Resources Company - Somers, NY

The Manager assumes responsibility for methodological and statistical aspects of a project or group of clinical studies, with general direction from Therapeutic Area lead biostatistician. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams. In some cases incumbent could serve as technical expert in a particular statistical area or application

Application Deadline: None

Senior/Principal Biostatistician

Alternative Resources Company - Somers, NY

The position assumes responsibility for methodological and statistical aspects of a project or group of clinical studies, with general direction from Therapeutic Area lead biostatistician. Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in one or more therapeutic areas / indications is required. In some cases incumbent could serve as technical support i...

Application Deadline: None

Medical Science Liaison - Southeast

Alternative Resources Company - Somers, NY

Due to expansion we are recruiting for Medical Science Liaisons (MSL's) with a successful track record who will be based around the United States. Candidates will have a thorough understanding of the pharmaceutical industry and current regulatory landscape. The field-based MSL team will function as experts representing Company and will establish peer-to-peer relationships with key opinion leade...

Application Deadline: None

Manager, Regulatory Affairs

Alternative Resources Company - Somers, NY

The Manager, Regulatory Affairs will report to the Director, Regulatory Affairs and, under the direction and guidance of the Director, insure global regulatory compliance of the company products throughout the product development cycle and monitor global regulatory developments potentially affecting the business. Product categories include OTC Monograph drugs, OTC NDAs, Medical Devices, Cosmeti...

Application Deadline: None

Manager, Corporate Pharmacovigilance

Alternative Resources Company - Somers, NY

• Leads the Pharmacovigilance team as part of our global drug product safety & surveillance mandate. Ensures that the company is complaint with GCP, GMP, ICH Guidelines and International Pharmacovigilance Regulations in the markets in which we do business.

Application Deadline: None

Executive Director, Clinical Development

Alternative Resources Company - Somers, NY

Reporting to the VP Clinical Development, the Exec. Director, Clinical Development, will be responsible for leading the global clinical product development, managing the clinical program as medical lead and providing ongoing clinical perspective to the research and development strategy for the company pipeline, from start or acquisition of compound to regulatory approval and other therapeutic a...

Application Deadline: None

Associate Manager - Manager, Regulatory Labeling (2 Positions)

Alternative Resources Company - Somers, NY

Manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPl, and EU SmPc. Maintains and appropriately archives submitted and approved labeling documents and packaging component labeling. Participates in the development of the labeling objectives early in product development to assist teams in creating development strategies to achieve these objectives

Application Deadline: None

Senior Manager - Quality Pharmacovigilance

Alternative Resources Company - Somers, NY

The Senior Manager – Quality Pharmacovigilance (PV) is responsible for performing domestic and international inspections that ensure compliance with the FDA and other worldwide health authority Drug Safety and PV regulations and guidelines, site SOPs, protocols, and industry standards, as applicable. This individual provides recommendations for corrective and preventative action and tracks corr...

Application Deadline: None

Senior Manager - Associate Director Regulatory Affairs

Alternative Resources Company - Somers, NY

• Maintenance of Drug Establishment Registrations (DER) covering all sites • Drug Listing, Create NDC numbers • Provide information on GDUFA requirements and GDUFA fees • Major driver of, develop and maintain the overall company US Regulatory strategy • Assist in the development and communication of and facilitate proper implementation of regulatory strategies on product specific issues • Fol...

Application Deadline: None

Lead, Technical Process Operations

Alternative Resources Company - Somers, NY

• This position carries the responsibility for the direct client interface during the development, scale-up, transfer, and /or commercialization of products. This includes batch record creation, review, generation of DOE and sampling protocols, validation documents, authorship of final reports and technical project guidance to the client. • Expertise in fluid bed processing is highly sought, a...

Application Deadline: None

Manager – Quality GMP

Alternative Resources Company - Somers, NY

The Manager – Quality GMP is responsible for independently performing domestic and international inspections that ensure compliance to the FDA and other worldwide health authority cGMP regulations and guidelines, site SOPs, protocols, and industry standards, as applicable. This individual provides suggestions for recommendations for corrective and preventative action to the Quality Senior Manag...

Application Deadline: None

Assistant Director - Quality GMP

Alternative Resources Company - Somers, NY

The Assistant Director – GMP Quality Assurance (QA) manages and coordinates GMP regulated QA activities from early stage development through commercial product. This individual is responsible for performing domestic and international audits/inspections ensuring compliance with the FDA and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards

Application Deadline: None

Senior Manager - Quality, GMP and Investigations

Alternative Resources Company - Somers, NY

Responsible for performing investigations related to product complaints and non-conforming events to ensure compliance to the FDA and other worldwide health authority CGMP regulations and guidelines, site SOPs, and industry standards. This individual provides recommendations for corrective and preventative action to the Quality Senior Management team. The Senior Manager – Quality, GMP & Investi...

Application Deadline: None