Job vacancy Senior Manager – Regulatory Affairs/Qppv

JOB BY
JobsinGhana
59 Okodan St, Blue Gate district, Osu, Accra near Papaye, Accra
  +233 0302 760143, +233 24 3925110

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Job Type
Temporary / Contract
Job Status
Full Time
Announced
15 May, 2021
Job Title

Senior Manager – Regulatory Affairs/Qppv

Job Location
Job Presentation
Company Profile

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
  •  Job SummaryThe 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
  • Requirements
    • 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
    • Education: B.Sc./M.Sc.
    Valid Till
    14 Jun, 2021


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