Regulatory Services Consultant
Population Services International (PSI)
Location: United States
Occupations: Legal Affairs
H Hardship
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Added 3 months ago
Job Description

Regulatory Services Consultant

Remote Location

Up to international travel

Reports to FWCA Regional Representative

Who we are

With over 45 years of experience, working in over 60 countries, Population Services International (PSI) is the world’s leading non-profit social marketing organization. PSI is reimagining healthcare, by putting the consumer at the center, and wherever possible – bringing care to the front door. We are working to fix market failures, shape future health markets and shift policy and funding to better support consumer empowered healthcare.

There are over 7,000 “PSI’ers” around the world. We are a diverse group of entrepreneurial development professionals with a wide range of backgrounds and experience. All with unique skills that we bring to the critically important work that we do.

Join us!

PSI is an international non-profit organization with operations in several Francophone West and Central Africa countries. Through regional funding, PSI is focused on unlocking access to affordable pharmaceutical and consumer health products across Francophone West Africa. PSI is assessing the landscape across Francophone West Africa to identify market gaps and analyse opportunities for potential offerings in the pharmaceutical and consumer health categories with an emphasis on sexual and reproductive health.

Compliance with regional and national pharmaceutical and consumer health regulatory frameworks in current and anticipated markets is critical to ensure that the organization is operating within applicable regulatory guidelines and standards and to facilitate the entry into market of new product and service offerings.

We are looking for a Regulatory Services Consultant to provide advice and support the documentation of regulatory requirements across the Francophone West & Central Africa region.

Sound like you? Read on.

Your contribution

PSI seeks to engage a regulatory consultant to provide advice and support for the following services in a number of countries across the FWCA region:

1. Documentation of regulatory requirements across Francophone West Africa, including

  • Identify and document variations and similarities in regulations across countries within the region
  • Identify any regulations that would prevent or hinder entry into a particular country
  • Confirmation of artwork, labelling and packaging requirements and regional harmonization for unique product offerings across Francophone West Africa

2. Registration of new product or service offerings, including

  • New dossier assessments and recommendations for filing, including labelling requirements, fast-track opportunities, and similar considerations to ensure swift and efficient processing
  • Review and submission of dossiers, including variants
  • Follow up on submissions
  • Review and preparation of responses to applications from regulatory authorities
  • Update / amend existing registrations to facilitate renewals, formulation changes, new / additional formulations, label amendments, etc.

3. Quality assurance and regulatory compliance, including

  • Review, compilation and submission of documentation required for registration and licensing or acquisition of necessary permits for entry into market
  • Policy development and review as guidelines are updated
  • Assistance with self-inspections, internal / external audits (manufacturer, warehouse / Distribution facility, pharmacovigilance, etc.)

What are we looking for?

The candidate we hire will embody PSI’s corporate values:

Measurement: You use hard evidence to make decisions and guide your work. You set clear goalposts in advance and explain clearly if you need to move them.

Pragmatism: You’ll strive to deliver the best possible result with the resources available. You won’t be paralyzed by a need to make things perfect.

Honesty: You own your mistakes and are open about your shortcomings – it’s the only way you’ll learn and improve.

Collaboration: You’ll quickly establish a mental map of whom you can rely on for what, on your team, at headquarters, and in our country offices – if you try to do it all yourself, you won’t succeed.

Trust: You accept limits to your sphere of control and give colleagues the benefit of the doubt

Commitment: You are in it for the long-haul and want to grow with the organization, just like PSI serves its consumers and partners with host-country governments through thick and thin

The basics

  1. Professional qualifications – Minimum qualification undergraduate degree in the sciences; Bachelor of Pharmacy preferred
  1. Breadth of expertise including but not limited to:
    1. Years of experience/years of operation/number of years in practice in the field
    2. Demonstrable success in securing product registration in FWCA
    3. Experience with the registrations of pharmaceutical products and medical devices
    4. Client profile
  2. Team large enough to prioritize work allocation efficiently and in multiple countries but not so large we aren’t a priority
  3. Experience across the entire Francophone West and Central Africa region
  4. Experience with dossier review
  5. Problem solving mindset – how to overcome challenges and deal with setbacks
  6. Pharmacovigilance services an added advantage
  7. Experience with regulatory and legal frameworks within the region
  8. Cost of Services
  9. Fluency in English and French

Services are to be provided on an as-needed basis over a period covering 18 months from the date of signature of the contract. Bidders pricing for the Financial Proposal should be based on the daily or hourly rates (and overhead or indirect rates, as appropriate) for the Consultant and his/her employees who will provide the services outlined in the terms of reference. Any anticipated changes to the fee schedule provided over the anticipated term of the contract (18 months) should be indicated in the offer

STATUS

  • Exempt

*Due to high volume of applications, only finalists will be contacted. Curious about your status? Please log into your iCIMS account to find out.

PSI is an Equal Opportunity Employer and encourages applications from qualified individuals regardless of actual or perceived race, religion, color, sex, age, national origin, disability, sexual orientation, marital status, personal appearance, matriculation, political affiliation, family status or responsibilities, gender identity or expression, pregnancy, childbirth, related medical conditions or breastfeeding, genetic information, amnesty, veteran, special disabled veteran or uniform service member status or employment status.

About PSI

Population Services International (PSI) is a global nonprofit organization focused on the encouragement of healthy behavior and affordability of health products.  PSI was founded in 1970 to improve reproductive health using commercial marketing strategies and has expanded to work in over 50 countries in the areas of malaria, family planning, HIV, diarrhea, pneumonia and sanitation. PSI is headquartered in Washington, DC.

A hallmark of PSI is a commitment to the principle that health services and products are most effective when they are accompanied by robust communications and distribution efforts that help ensure wide acceptance and proper use.

PSI works in partnership with local governments, ministries of health and local organizations to create health solutions that are built to last.