Company Profile

DKT Anglophone West Africa (AWA), is an innovative, adventurous and sustainable social marketing enterprise that improves people’s lives in Ghana, Liberia and Sierra Leone by contributing to raising modern contraceptive prevalence rate, reduce maternal mortality and provide safe quality options for HIV/AIDs prevention.  

Job Description

• Title: Senior Manager – Regulatory Affairs/Qppv
• Department: Regulatory Affairs
• Directly reports to: Country Director 
• Directly supervises: Assistant Manager - RA

• 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

Required Skills or Experience

Abilities

• Experience with regulatory submissions, including IDNs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential
• Ability to handle multiple assignments and good judgement in prioritizing tasks
• Demonstrated ability to work independently and within a group setting, and to interact with various departments and functional groups
• Ability to push regulatory bodies to meet deadlines (Keeping accurate records of all interactions with regulatory authorities; manufacturers and supplies)
• Strong communication skills and highly influential, and  the ability to identify and recommend solutions to problems
• High level of attention to detail, and proficient with Microsoft Office applications, Adobe and Excel
• Liaison between the company and the Pharmaceutical Council; FDA and other regulatory authorities

Position Requirements

Minimum Education

• A minimum of first degree from a recognized institution or other relevant discipline
• Master’s degree in public health is a plus
• Qualified Person for Pharmacovigilance, certified

Work Experience

• Minimum 3 years’ experience in similar position
• Experience with and understanding of Ghana’s law providing access to safe abortions, FP and MVA services. 
• Proven knowledge of the private clinic landscape in Ghana, with existing strong relationships and networks within the sector.
• Proven skills in organizing community related activities

Skills and abilities

• Proven leadership skills
• Strong interpersonal and people management skills
• Entrepreneurialism 
• Innovation and risk-taking
• Strong organizational skills
• Strong attention to accuracy and detail
• Flexibility
• Personable, approachable demeanor
• Effective time-management
• Integrity and honesty
• Excellent writing & oral communication skills
• Fluent in English