OPEN POSITIONS

US Nano Food & Drug seeks a highly motivated individual to fulfill the position as Regulatory Affairs Manager. The candidate will provide support to the Regulatory Affairs department in preparation of regulatory documents, providing regulatory expertise to ensure compliance of studies to all Federal Regulations, who will directly report to the CEO. 

Responsibilities:

• Performs day-to-day regulatory activities for all IND/NDA projects, including submission of all required filings

• Tracks recurring regulatory activities and manages submission timelines

• Conducts regulatory review of materials related to labeling, advertising and promotion of generic drug products

• Responsible for global pre-market clearance or approvals as required. Manages and implements effective Regulatory Affair strategy. Ensures maintenance of product approvals and complete necessary notifications, supplements, amendments, listings, and annual reports required for products on a worldwide basis.

• Routinely monitors regulatory intelligence, including new FDA guidance/impact assessments

• Develop regulatory affairs internal policies and procedures, and provide internal trainings trainings as and when required.
  
  Requirements:

• A bachelors degree in chemistry is strongly preferred

• At least 5 years of  regulatory experience 

• Experience of communicating with Regulatory Authorities 

• Experience in 505 (b)(2) drug registration, regulatory audits, ISO certification, GMP requirements and document control

• Manufacturing sterile injectable drug products under cGMP experience is a plus.

• Ability to work independently, self-starter

• Intermediate International travel is required
  
  Job Type: Full-time
  
  Salary: $85,000- $120,000 /year 

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