Regulatory Affairs Manager at Global Channel Management, Inc in Madison, NJ

Regulatory Affairs Manager needs 5+ years’ experience

Regulatory Affairs Manager requires:

Ø FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations.

• Pertinent Federal and State laws related to pharmaceutical regulatory affairs.

• Supervision and training practices and methods.

• Business, scientific and personal computer software applications.

• Business English usage such as, spelling, grammar and punctuation.

• Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.

• Company policies, practices and procedures, including safety rules and regulations.

• Principles and practices of budget preparation and administration.

Ø Creating, planning and implementing group goals, objectives and practices for effective, efficient and cost effective management of allocated resources.

Regulatory Affairs Manager duties:

• Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.

• Directs, coordinates and prioritizes the daily activities of the assigned staff.

• Reviews and approves regulatory submissions (i.e. NDAs, amendments, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance’s.

• Interacts with various departments as needed on regulatory issues and/or strategy. Effectively guides, communicates and implements determined strategy with the appropriate departments and/or employees.

• Review and approve change notices, specifications, batch records, standard test methods, etc.

• Implements policies to assure on-going compliance of Regulatory Affairs activities.

• Assesses impact of new regulations and suggests appropriate changes to business processes/policies as necessary.

• Interacts with the FDA to facilitate approval of the regulatory submissions.