SST Corporation is looking for a candidate to fill a position of Regulatory/Technical Affairs Senior Manager/Director. The Regulatory Department carries out all necessary tasks to keep SST and all of our suppliers current and in good standing with the FDA. The primary responsibility of this position is to oversee all aspects and operations of the SST Regulatory Department. It also provides Regulatory support as necessary to sales, supplier management, other SST departments and all of our customers and suppliers. Another aspect of the position is long term strategic thinking: ie, to develop novel, strategic initiatives that benefit SST’s customers and/or suppliers.
Oversee all aspects and operations of the Regulatory Department, including technical issues.
Accompany Account Managers on customer calls, when necessary.
Assist Account Managers in the conduct or a project, when necessary.
Remain current with the latest FDA regulations and guidelines and filing requirements, especially related to APIs.
Mange regulatory and technical requests from Customers and Suppliers
Respond to internal regulatory and technical requests from within SST
Manage Customer complaints, investigations and return of product
Resolve Customer specification and analytical method issues
Review of US DMF amendments, annual reports, deficiency responses and providing feedback to DMF holders (Suppliers).
Provide guidance on filing mechanisms to customers for post approval changes to processes, specifications, analytical methods, container closure, etc.
Manage GDUFA Self-ID, Facility fees, DMF fees and Establishment Registration, etc. by Suppliers to ensure compliance with GDUFA regulations
Manage audits by FDA, DEA, US Customs, NJ DoH and customers
Conduct internal/external audits to ensure compliance with SST’s GMP related SOPs
Coach and mentor Regulatory colleagues
An advanced degree (MS/PhD) in Analytical or Organic Chemistry is required
Minimum of 10 years in a new drug pharmaceutical environment performing process research and/or manufacturing.
Minimum of 5 years experience in Regulatory Affairs as it relates to Post Approval Changes to the Active Pharmaceutical Ingredients and/or Drug products
Strong technical knowledge and through understanding of all FDA requirements pertaining to regulatory submissions
Familiarity with ICH and FDA Guidance for Drug Substance and Drug Product regulations is desired
Familiarity with GDUFA, import/Export Regulations is desired
Effective verbal and written communication skills
Additional Salary Information: Based on experience
Internal Number: SST1
About SST Corporation
SST is a full-service pharmaceutical agency that represents world-class manufacturers of active pharmaceutical ingredients (APIs) and fine chemicals and intermediates (FCIs). Our audited network of global suppliers provide gram to commercial-scale production of APIs and FCIs, as well as custom synthesis. We bring substantial added value to this service with in-depth regulatory and technical expertise and processing, supply-chain management and other services.