Jobs at Alternative Resources Company

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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

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

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

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

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

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

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 Director Therapeutic Area Project Management

Alternative Resources Company - Somers, NY

Develops, drives, and directs operational plans for conducting clinical research, producing publications, and regulatory submission documents. Provides project management leadership and oversees/manages the planning, design, implementation, and completion of clinical research activities and regulatory correspondence.

Application Deadline: None

Manager, International Regulatory Affairs

Alternative Resources Company - Somers, NY

The Manager, International Regulatory Affairs will report to the Director, Regulatory Affairs and, under the direction and guidance of the Director, will work to obtain market authorization for OTC drugs and medical devices outside the U.S. The Manager will also correspond with foreign regulatory authorities and the company’s international distributors as needed to ensure that all products dist...

Application Deadline: None

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

Senior Director, Supply Chain

Alternative Resources Company - Somers, NY

The Sr. Director, Supply Chain QA will establish and maintain the Disposition Quality System for company aligned with regulatory requirements and company Quality policies. He/she will provide quality oversight of company contractors to support the manufacturing, testing, release and distribution of clinical and commercial products and medical devices to approved jurisdictions. This includes ove...

Application Deadline: None

Director, Compliance and Audits

Alternative Resources Company - Somers, NY

The Director Compliance and Audits will establish and maintain the global Supplier Quality Management System for company aligned with regulatory requirements and Quality policies. He/she will ensure that all GXP suppliers are qualified and audited in compliance with company SOP’s. The incumbent will develop the external audit schedule and manage the program using internal and external auditors....

Application Deadline: None

CAPA MANAGER

Alternative Resources Company - Somers, NY

Will oversee the GMP process for the company Corrective and Preventive Action system. This role will drive this process for QA with emphasis on compliance to company SOPs and applicable Regulatory requirements. The CAPA Manager will interact with key stakeholders in the organization as well as third parties for the timely and accurate generation and approval of CAPAs and PAs. This role will lea...

Application Deadline: None