REGULATORY AFFAIRS MANAGER
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.
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.
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
US Nano Food & Drug seeks a highly motivated individual to fulfill the position as Analytical Scientist. Highly skilled Analytical Scientist with experience in analytical method development, method validation, specification development.
• Independently conducts complex analyses with a thorough understanding of laboratory procedures.
• Writes/revises Standard Operating Procedures (SOPs), analytical methods,
protocols and technical reports.
• Preparing the document of CTD formal for submission to FDA.
• BS degree in pharmaceuticals or Chemistry with 10+ years of relevant experience
• MS in pharmaceuticals with 7+ years of relevant experience
• Track record of analytical method development and validation
• Knowledge of cGMP, USP, FDA and ICH guidelines related to method development
Job Type: Full-time
Salary: $65,000- $100,000 /year
Interested candidates should submit their resumes to firstname.lastname@example.org