Director, Regulatory Affairs
Director, Regulatory Affairs
Our client is seeking a qualified professional for the position of Director, Regulatory Affairs, reporting to the Chief Scientific Officer. The incumbent will be based in USA and is expected to effectively coordinate with Product Development group at global sites, international contract development organizations, and third-party service providers. The incumbent is responsible for providing leadership and oversight of regulatory activities related to pre-submissions and post-approval of US products with FDA.
- Lead and direct an integrated regulatory program related to ANDA and 505(b)(2) products for submission to FDA, including active engagement and formal communication with the Agency.
- Detailed content-review of dossiers for submission to FDA. Such a review includes areas related to drug substance, formulation, analytical testing, stability, and manufacturing through packaging. Conformation to regulatory standards suggestive of FDA and ICH guidelines must be adhered to.
- The incumbent is expected to provide CMC advice on product development through dossier filing, pre- and post-submission communications with FDA, controlled correspondences, pre-ANDA meetings, pre-submissions meeting, citizen petitions, dispute resolutions, responses to deficiencies, post-approval changes, due diligences on product licensing / acquisition, and participation at FDA meetings.
- Detailed CMC review of dossiers in accordance with US FDA standards of acceptability and essential completeness of eCTD modules.
- Technical review of dossier must allow for Acceptance to File (ATF), avoid any Refuse-to-Receive (RTR) comments from FDA, and confirm robustness assessment of the dossier, thereby leading to a meaningful prediction of FDA approval timelines.
- Master’s degree or higher in Science or related field, with at least 15 years of experience in US Generics pharmaceutical industry.
- Accomplished professional with strong US FDA regulatory background and at least 12 years of experience in CMC review of scientific details required for presenting and compiling procedures, data, results, and commentary on pharmaceutical products for ANDA and 505(b)(2) submissions.
- Minimum of 4 years of prior hands-on experience in formulation development or analytical testing of pharmaceutical dosage forms related to oral and injectable dosage forms.
- Detailed understanding of generic product development, dossier-filing, and approval.
- Current understanding of regulatory requirements related to Quality by Design, and interpretation of FDA guidances that are applicable to product development phase through commercialization.
- Well-acquainted with not-yet-established or evolving regulatory trends at FDA through seminars and workshops to pre-empt the planning and execution processes on product development programs.
- Areas of technical experience includes CMC knowledge and good understanding of characterization studies required for drug substance, finished product, and container closure systems, along with specifications setting and product performance.
- Essential professional attributes include a detailed-oriented professional with analytical thinking, a team-player attitude, respect and understanding for cultural differences in different countries, efficient utilization of time and resources, and adaptability due to differences in time zones.
- The intended role and responsibilities require that the incumbent will work remotely, but be flexible in committing to domestic and international travels to about 15% of total time.