Regulatory Affairs Operations Associate Jobs in Iowa

Effectively monitor and track information and requirement changes

Maintain compliance with regulatory requirements and regulatory databases for generic drugs for the US market.

Adhere to all health, safety & environmental (HSE) requirements in support of departmental and site HSE goals

Excellent oral and written communication skills

Pharmaceutical or generic drug experience in a regulatory capacity

Lab experience and familiarity with Abbreviated New Drug Application (ANDA) and/or Electronic Common Technical Document (eCTD)

Management Strong management with depth of experience working for global health authorities.

Experience with project lifecycle and management

Strong management with depth of experience working for global health authorities.

Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support.

Interacts professionally at multiple levels including senior management within a client organization.

Successfully penetrates executive management levels or other business units within a client organization.

Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions also desirable

Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents

Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (nonclinical, clinical)

Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations

Project Management - Communicates changes and progress; Completes projects on time and budget.

With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical and non-clinical