Job for a Regulatory Professional in a Multi National Pharmaceutical Company in Nigeria
Kinetic Business Solutions is a dedicated, committed and niche provider
of effective human resource solutions to the Pharmaceutical, Medical
Device and Healthcare industries.
Sector expertise is at the heart of
everything we do, recruiting the best talent and building long lasting
relationships. With specialist knowledge and proven experience in
international recruitment, our consultants are continuously striving to
go one step further by spending time to gain empathy and thereby truly
understand our client's specific requirements, individual culture,
unique working environment, organisation ethos and principal values.
Job Title: Regulatory Professional
A top tier Multi National Pharmaceutical company and Global leader are
now looking to hire a Regulatory Professional to be based in Nigeria,
and report directly to the Regulatory Lead for SubSaharan Africa.
The
Regulatory Professional will support submissions, approvals and
maintenance of Marketing Authorization Application (MAA) for projects in
Nigeria. Other responsibilities will include:
- Participate in project meetings with appropriate members of the EMEA Regulatory Affairs team.
- Together with the EMEA Regulatory Leader provide both strategic and tactical regulatory support to Projects.
- Act as primary point of contact with regulatory health authority and/or company appointed legal trade representative.
-
Assist with timely MAA availability, ensure that all document
components are in place on time, identify and track critical path
activities
- Provide regulatory support throughout the
registration process and the life-cycle of the product, including
support to the company Distributor to ensure the timely follow up of
approval applications. As well as acting as liaison between the
Distributor and Internal Teams
- Lead the transfer of Market Authorisation Holder Transfers in a timely and effective manner
- Ensure appropriate and timely responses and follow-up to Health Authority comments and/or questions received.
-
Develop and ensure effective implementation of national regulatory
strategies and tactics in support of the global development and
life-cycle management plans.
- Provide input for the PI based on
an understanding of the implications of the regional regulatory
strategy for labelling; Manages artwork; Ensure labelling compliance in
the region and document it in the appropriate system.
- Ensure appropriate electronic archiving of all communications from or to the Regulatory Agencies
-
Maintain planned and actual regulatory submission dates (including
dossier submissions and Regulatory Agency responses) in the appropriate
systems (eg SPS, MPD/PKB)
- Contribute to standardisation/new systems and processes to ensure efficiency gains and to support continuity
-
Contribute to compliance with all regulatory requirements (e.g. timely
submission of dossiers, post-marketing commitments, renewals, timely
implementation of new national and international legislation, timely
implementation and training of SOP’s & supporting systems).
- Develop a deep understanding of the regional regulatory environment, competitor intelligence and disease area.
-
Act as the designated quality assurance pharmacist and provide, inter
alia, effective management of product complaints, recalls, compliance
(including artwork).
Required Qualifications Requirements
- University
degree - medical or paramedical (pharmacy, biology, veterinary etc.),
or equivalent by experience 6-8 years related experience in
pharmaceutical industry in Sub Saharan Africa, particularly in the
Nigerian environment
- Experience in some or all of the following
pharmaceutical functions would be an advantage, particularly in
Nigerian environment : regulatory, PV and quality.
- Experience
in managing third parties intermediaries or significant experience in
working with third party regulatory intermediaries
- Strong knowledge of general regulatory requirements and guidelines
- Project teamwork and/or matrix organisation experience
- Knowledge of and relationships with the Nigerian regulator
Skills
- Ability to manage multiple tasks, projects, priorities,and complex systems simultaneously
- Ability to work in a matrix organization and participate effectively both independently and as part of multiple teams
- Project management skills
- Strong Interpersonal and communication skills, supervisory skills, and presentation skills are a must
- Fluency in English. Knowledge of French is highly preferred
- Ability to work under strict timelines, combined with flexibility when emergency situations require this.
- Knowledge of company standardised computer software
- Ability for decision making, working under pressure, and exercising good judgment on special situations.
-
Capacity to be aware, abstract, analyze, calculate, catalogue,
classify, compare, coordinate, copy, detect, diagnose, edit, estimate,
evaluate, influence, inspect, instruct, interpret, read, measure,
negotiate, observe, plan, group, organize, supervise, synthesise, and
select
How to Apply
Interested and qualified candidates should
Click Here to Apply