Jobs at Alternative Resources Company

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Senior Manager / Associate Director, Regulatory Affairs (Ophthalmology)

Alternative Resources Company - Somers, NY

This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of the company’s quality, preclinical and clinical drug development programs, policies, and procedures, so that Development teams are able to meet all objectives within specified timelines and so that the necessary state of complian...

Senior Manager / Associate Director, Regulatory Affairs (RA/Pain)

Alternative Resources Company - Somers, NY

This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of the company’s quality, preclinical and clinical drug development programs, policies, and procedures, so that Development teams are able to meet all objectives within specified timelines and so that the necessary state of complian...

Director Regulatory Affairs, Strategy

Alternative Resources Company - Somers, NY

Looking for a creative and flexible individual with strong spoken and written communications skills and is able to navigate in a diverse cross cultural cross functional environment.

GMP Training Specialist

Alternative Resources Company - Somers, NY

The individual in this position will have the responsibility of designing and delivering GMP, technical, and organizational development training (both classroom training and e-learning), along with assisting functional areas with developing competency training. This includes training in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill develo...

Quality Control Manager

Alternative Resources Company - Somers, NY

Directly and through subordinates and peers, the Manager of Quality Control Laboratories leads a multifunctional team comprised of Quality Control Chemistry & Microbiology, QC Technical Support, and Laboratory Equipment Validation/Metrology.

Quality Assurance Manager

Alternative Resources Company - Somers, NY

Has extensive knowledge of Quality Assurance and Control in general and the Quality Management System (QMS) in compliance with 21CFR part 11/210/211 specifically, and has to work closely with Quality Site Management team.

Associate Director, Medical Writing (Neuroscience & General Medicine)

Alternative Resources Company - Somers, NY

• The Associate Director, Medical Writing will be the designated Lead Medical Writer for approximately two neuroscience programs, responsible for providing needed support and direction to other staff/contractors with regard to them. • As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds...

Senior Manager, Global Regulatory Affairs - Neuroscience

Alternative Resources Company - Somers, NY

The Sr. Global Manager, Regulatory Affairs - Neuroscience will develop and implement regulatory strategies to facilitate optimum global approval of new medicinal products. This position contributes to the planning, execution and assessment of product life cycle management activities and strategies. In addition, this person contributes to the clinical development plans, global regulatory strateg...

Associate Director, Marketing Strategy (Oncology)

Alternative Resources Company - Somers, NY

The Associate Director, Marketing Strategy will ensure the effective marketing for the approved indications of an Oncology product. This will entail developing marketing strategy and plans to attain therapeutic area sales and profits, development of business plans, brand strategies, and tactical implementation

Associate Director, Contracts & Pricing

Alternative Resources Company - Somers, NY

Responsible for Commercial and Part D Contracting from bid to execution, Government Contracts administering the company’s contractual obligations under the Center of Medicare & Medicaid Services (CMS), Federal Supply Schedule (FSS) and Public Health Service Agreement (PHS). Managing the Subcontracting Small Business Plan according to FSS contractual obligations in regards to reporting requireme...

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...

Vice President – Senior Vice President, Regulatory Affairs

Alternative Resources Company - Somers, NY

A leader to champion regulatory efforts for the generic and specialty business. This individual will have extensive experience and in-depth knowledge of US regulatory requirements, and would ideally have a working knowledge of international filing strategies and requirements in other key markets throughout the world. In addition, this individual should have strong leadership skills as well as e...

Director, Program Development & Business Planning

Alternative Resources Company - Somers, NY

The Director Program Development & Business Planning will have a mixed role with responsibility for the business unit budgeting & finance, managing business development opportunities, and managing selected new and existing alliances. The precise distribution between these tasks will vary depending on the status of individual projects. Due diligence projects and alliances may be global in scope....

Regulatory Submission Project Planning Associate/Specialist (2 Roles)

Alternative Resources Company - Somers, NY

Responsible for project management of Regulatory submission deliverables such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (FDA, EMA, ICH).

Associate Director, GCP Inspection Management

Alternative Resources Company - Somers, NY

This position reports to the Director, Inspection Management, Clinical Compliance & Training. This will be a hands-on position that will be responsible for supporting the organization in planning, preparing and conducting GCP/GPV/GLP inspections by regulatory authorities (e.g. FDA). This will include, but not limited to, inspection readiness activities (e.g. start-up and gap assessments), inspe...