Regulatory Affairs Specialist (Sub Saharan Africa) At Stresert Services Limited In Lagos State

Job Details

Job Title: Regulatory Affairs Specialist (Sub Saharan Africa) At Stresert Services Limited In Lagos State
Organisation: Stresert Services Limited
Location:
Min Work Experience: 4 year(s)
Qualification: B.Sc
Industry:
Course: pharmaceutical,healthcare,medical
Recommended links

Job Vacancy Description

StreSERT is a professional services organisation that offers quality stress-free solutions to corporate organisations. We offer business support and integrated solutions in different areas that ensure business objectives are achieved. Critically, we evaluate issues as they impact your business, and consequently deploy the appropriate skills and competencies to proffer the needed solutions. Our Brand Driver At StreSERT, we believe that living by a set of core values help define the true measure of a company; they guide the way we treat each other and how we make business decisions, regardless of time, situation or person. They are the very essence of our company culture; the soul of our company. Ours is about building an organisation that has purpose, focus and alignment, which lives its values every day and creates an environment that allows employees to grow and to produce superior results. Our Vision: To be the preferred Human Resources and Integrated Enterprise Solutions provider. Our Mission: We lead in the provision of quality, flexible and result-oriented support solutions that will impact our clients’ businesses profitably.

Job Title: Regulatory Affairs Specialist (Sub Saharan Africa)

Job Type: Contract , Full Time

Qualification: BA/BSc/HND

Experience: 4 - 5 years

Location: Lagos

Job Field: Pharmaceutical 

Our client is a multinational Pharmaceutical organization. They seek the services of a Regulatory Affairs Specialist for a 2 years contract engagement.

Department: RA (Global Drugs Development) GDD

Reports to: RA Head

 – 2 YEARS CONTRACT

Job Purpose

  • Support the region (Sub Saharan Africa - SSA) with lifecycle maintenance activities
  • Coordinate submission of post-approval changes including variations and renewals for the region (SSA)
  • Coordinate update of (Chemistry Manufacturing & Controls - CMC) database when there are changes in country regulations and/or requirements
  • Maintain all necessary databases (e.g. DRAGON) to ensure regulatory compliance at all time.
  • Maintain open communication with the different stakeholders and regularly provide information when required.

Major Accountabilities

  • Ensure the RA CMC database for the different countries in the region is up to date
  • Evaluate post-approval changes for impact on product supply and communicate to stakeholders accordingly
  • Ensure submission of post-approval changes such as production transfers, MAT and pack size extension are done on-time and approvals received early enough to ensure smooth implementation
  • Ensure that submissions for license renewal are done in good time before license expiry so as to achieve early approval
  • Support the update local/Regional Working Practices or SOPs when required.
  • Ensure adherence to Global and local/regional processes.
  • Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary
  • Ensure compliance to global and local KPIs.
  • Develop and maintain good working relationships with other company functions/departments both locally and globally, as well as with health authorities as required

Key Performance Indicators

  • Ensure compliance with relevant Health Authority guidelines and regulations
  • Ensure all post-approval changes are submitted on time and follow up for approval
  • Meet product re-registration due dates and escalate possible adverse impact due to loss of license accordingly
  • Accurate maintenance of relevant regulatory information management system
  • Achieve Regulatory compliance deliverables as per global targets
  • Address issues related to compliance with urgency with escalations as appropriate
  • Share emerging regulatory intelligence with RA Heads
Requirements
Minimum years of experience

4

Qualifications
B.Sc
Other Requirements

ROLE PROFILE

  • Education:     B. Pharm       
  • Languages:     Fluent in English (mandatory)
  • Experience:    At least 4-5 years RA experienc
  • Good communication and negotiation skills
  • Good knowledge of CTD dossier format
  • Detail-oriented and organized
  • Good inter-personal skills

Application:

Candidates with a similar background who do not hold permanent employment should forward CVs to ‘recruitment@stresertservices.com’ using ‘RAS-2YR’ as the subject of mail before 1st March, 2020. Applicants without the aforementioned background and experience need not apply.

APPLY HERE
Click here to view most recent jobs posted today

  • Email me jobs like this

    LATEST RELATED JOB VACANCIES IN NIGERIA


    Laravel Backend Developer At TranSave Technologies Limited
    TranSave Technologies Limited in (Abuja)
    TranSave Technologies Limited - The only payment solution you need for business or personal transactions. From Payments to POS, Lo... Read more

    Psychologist At Olive Prime Centre
    Olive Prime Centre in (Abuja)
    Olive Prime Centre, we are committed to providing individuals with a flexible pathway to full recovery. We intend to provide suppo... Read more

    Independent Sales Agent At PecanTrust Microfinance Bank Limited
    PecanTrust Microfinance Bank Limited in (Lagos State)
    PecanTrust Microfinance Bank Limited "the Bank" is a financial licensed by the Central Bank of Nigeria. We offer a wide range of f... Read more
    View all

    LATEST JOBS BY STATES


    Recent Jobs in Abia

    Recent Jobs in Abuja

    Recent Jobs in Adamawa

    View all

    JOBS BY INDUSTRIES


    Accounting/ Audit/ Finance Jobs

    Administration/ Office/ Operations Jobs

    Advertising/ Social Media Jobs

    View all

    RELATED JOBS


    Laravel Backend Developer At TranSave Technologies Limited
    TranSave Technologies Limited in (Abuja)
    TranSave Technologies Limited - The only payment solution you need for business or personal transactions. From Payments to POS, Lo... Read more

    Psychologist At Olive Prime Centre
    Olive Prime Centre in (Abuja)
    Olive Prime Centre, we are committed to providing individuals with a flexible pathway to full recovery. We intend to provide suppo... Read more

    Independent Sales Agent At PecanTrust Microfinance Bank Limited
    PecanTrust Microfinance Bank Limited in (Lagos State)
    PecanTrust Microfinance Bank Limited "the Bank" is a financial licensed by the Central Bank of Nigeria. We offer a wide range of f... Read more
    View all

    LATEST JOB VACANCIES


    Business Development Manager At Lead Enterprise Support Company Limited
    LEAD Enterprise Support Company Limited in (Lagos State)
    We require the services of an experienced Business Development Manager with a wide range of business clientele and a network of c... Read more

    Floor manager at automobile repair garage
    jd autos center in (Lagos State)
    Regulate day-to-day operations of unit in conjunction with Departmental Heads, Manager, Executive Chef, Security. Cordinate and l... Read more

    FINANCE OFFICER
    LEAD Enterprise Support Company Limited in (Lagos State)
    Job Objective: The Finance Officer will assist the Finance/Admin Manager in the implementation of the HMO’s accounting policies an... Read more
    View all jobs

    Copyright © 2024 All Right Reserved CVClue
    A Subsidiary of EMINENT INFO TECH VENTURES