The Director, Regulatory Affairs, promotes and develops initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives with regards to FDA submissions. Acts as an adviser to subordinates.
Reviews all regulatory submissions, including ANDAs, amendments, supplements etc., for following dosage forms to ensure high quality submissions with an overall objective to receive approval within the shortest time frames possible: topical ointments, creams, gels, solid orals (tablets & capsules), liquid orals (suspension and solutions), nasal spray solutions.
Provides daily direction and supervision to Regulatory Affairs staff including administrative, technical, documentation support, and regulatory submission management functions.
Interacts with Product Development, Analytical Development, QA/QC, Operations, and purchase teams as needed to provide guidance with respect to regulatory issues and to get support from them for the regulatory team.
Provides advice, regulatory guidance, and status reports to senior management, as appropriate.
Ensures timely submission of all projects with USFDA .
Maintains current knowledge of regulations and other issues that affect products and industry.
Monitors status of ANDAs, controlled correspondence and supplements submitted with USFDA.
Follows up with FDA when necessary to obtain the status of these submissions.
Master Degree (MS/MA) Pharmacy or related field - Preferred
Bachelors Degree (BA/BS) Pharmacy or related - Required
10 years or more in Regulatory Affairs and Formulation development
Must have knowledge of ANDAs, ICH and FDA regulations, product dosage forms, 21 CFR and cGMPs. - Intermediate
Ability to use Word, Excel, Outlook and Adobe Acrobat. - Intermediate