DKT International Inc. is a non-profit organization whose core mission is the provision of safe and affordable options for family planning and HIV/AIDS prevention. DKT operates 24 programs in 25 countries worldwide
The company is seeking a highly motivated and influential Pharmacist to lead its product development, product registration and regulatory affairs Title: Senior Manager – Regulatory Affairs/Qppv
Department: Regulatory Affairs
Directly reports to: Country Director
Directly supervises: Assistant Manager - RA
The Senior Manager Regulatory Affairs and Qualified Person for Pharmacovillance (QPPV) will work closely with the Country Director and is accountable for the preparation and management of simple and complex regulatory submissions. Act as a single point of contact for the FDA on all matters relating to pharmacovigilance and safety of marketed products including pharmacovigilance inspections. Establish and maintain a system which ensures that information about all suspected adverse drug reactions/events which are reported to the personnel of the marketing authorization holder, including to medical representatives, is collected, collated, processed and evaluated and forwarded to the Authority in line with the timelines stipulated by the Authority. The incumbent will work independently and within a group setting to act as liaison between Regulatory Affairs and other functional areas including external regulatory bodies, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to government regulatory agencies. This individual will have a solid understanding of FDA regulations and GSA guidance’s and experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format. The candidate will have excellent written and verbal communication skills, proficient in project management, be flexible, and able to work in a fast paced environment where accuracy and speed are paramount. Specific Duties and ResponsibilitiesReporting to the Country Director, the Senior Manager (RA/QPPV) will: Actively lead the development of new products and implementation of regulatory strategies for assigned projects.
Lead the registration of new commodities/drugs with the FDA
Timely compile materials for license renewals, updates and registrations
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes and ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
Provide thoughtful & accurate comments during document review (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.), mindful of regulatory/ICH guidance/requirements pertaining to document content.
Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
Prepare the following for submission to the Authority;adverse drug reaction reports
Periodic Safety Update Reports (PSURs)/Periodic Benefit-Risk Evaluation reports (PBRER), when necessary
company-sponsored pre- and post-registration study reports
Risk Management Plan (including Ghana Specific Risk Management Plan) when requested by the Authority
Ongoing pharmacovigilance evaluation during the post-registration period.
Ensure that any request from the Authority for additional information deemed necessary for the evaluation of the risk-benefit ratio of a marketed product, is provided to the Authority promptly and fully.
Oversee the safety profiles of the company’s marketed products and any emerging safety concerns.
Any other responsibilities assigned by the Country Director.
Core Job Responsibilities:
Represent Regulatory Affairs on DKT product development to ensure all regulatory requirements are met throughout the development process.
Complete submissions to FDA and GSA regulatory entities.
Create and maintain systems for Adverse Drug Reporting.
Review advertising and marketing materials for appropriateness and compliance to regulatory requirements and laws.
Implement pharmacovigilance activities
Provide input into Risk Management Plan when necessary
Prepare and report on regulatory actions to emerging safety concerns (e.g. variations, urgent safety restrictions, and, as appropriate, communication to Patients and Healthcare Professionals)
Provide clear backup plans when absent from duty including leave or travel
Provide oversight regulatory responsibilities for commodities from manufacturer through warehousing to sales outlets