alternative resources company Jobs

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Senior Director, Global Regulatory Strategy

Alternative Resources Company - Somers, NY

Provide guidance and oversight to Global Regulatory Strategists with regard to the development and implementation of global regulatory strategies to ensure alignment to TA portfolio and that key regions are captured in the global regulatory strategy; develop Regulatory Strategy for directly assigned projects by designing and assessing regulatory strategy options on a regional and global basis (...

Application Deadline: None

Deputy Director, Global Medical Affairs Publications

Alternative Resources Company - Somers, NY

Contributes to the Global Publications Strategy, and develops and implements the Global Publications Plan for the company’s ophthalmology portfolio. Scientific publications represent one of the most important sources of reliable and credible information for practicing physicians and this role will ensure the presentation and publication of the clinical trial results in a manner compliant with t...

Application Deadline: None

Director, US Regulatory Affairs - Nutritionals/GI

Alternative Resources Company - Somers, NY

• Lead and manage US Category team resources and facilitate their development through individual development plans and performance assessment • Oversee development and implementation of new product regulatory strategies in the US, considering the different legal status of the products, resulting in timely product approvals in the US • Proactively identify regulatory issues/risks and design/exec...

Application Deadline: None

Associate Director - Director, Regulatory Affairs

Alternative Resources Company - Somers, NY

This position will function as the US Regulatory Affairs expert to develop and implement US Regulatory strategy. This individual will maintain and interpret updated knowledge of US guidelines, counsel and guide global colleagues and interact and negotiate directly with the Regulatory Agency.

Application Deadline: None

Senior Manager - Associate Director, Quality Assurance

Alternative Resources Company - Somers, NY

Responsible for implementation of quality system and overseeing all quality related functions within the facility. The primary function is to ensure compliance with all regulatory agency requirements, as well as internal quality system requirements. This includes – but is not limited to – quality system implementation and maintenance, documentation management, training, internal and external au...

Application Deadline: None

Manager / Sr. Manager, Biostatistics

Alternative Resources Company - Somers, NY

Provides leadership and guidance as the statistical expert on a project team, with minimal direction from Therapeutic Area lead biostatistician. Accountable for all statistical aspects of project studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. May have regional or global management responsibility. In some cases, incumbent could serve as ...

Application Deadline: None

Principal Statistical Programmer

Alternative Resources Company - Somers, NY

Provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. The i...

Application Deadline: None

Director, Global Labeling

Alternative Resources Company - Somers, NY

The Director, Global Labeling is responsible for the leadership and oversight of the Labeling function within Global Regulatory Affairs (GRA). This position will manage labeling operations and actively contribute to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. Reporting to the Head of Global Regulatory Op...

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

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

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

Pricing Supervisor

Alternative Resources Company - Somers, NY

Responsible for the development, implementation and continuous review of a customer pricing guideline grid utilizing competitive market data and overall company profitability goals to ensure a competitive and profitable pricing strategy. Responsible for ensuring the proper pricing relationship exists between direct customer prices, indirect customer prices and indirect wholesaler source prices ...

Application Deadline: None

Global Technical Support Specialist

Alternative Resources Company - Somers, NY

Global Technical Support is the main contact point for our customers world-wide and responsible for providing technical support to our customer with regards to our products, both API’s and Finished products. Global Technical Support is the added value to our products and the team must act in close cooperation with the regional sales people thereby maximizing sales. Technical Support participate...

Application Deadline: None

Supervisor, Contracts

Alternative Resources Company - Somers, NY

Responsible for core financial, pricing, rebate and contractual language review functions in support of the customer relationships including but not limited to customer contract compliance and profitability, ad hoc price challenges, annual pricing bids, customer contract agreement review and product target modeling. Responsible for creating the Business Analyses in order to review customer prod...

Application Deadline: None

Regulatory Submission Operations Associate II

Alternative Resources Company - Somers, NY

Responsible for building Regulatory submissions such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).

Application Deadline: None