Associate Director Regulatory Affairs EMEA GPH Liaison (Vaccine Programs)
Preferred Locations : Morocco, Ghana, Kenya, South Africa, Nigeria, United Kingdom (High Wycombe), Belgium (Beerse), Netherlands (Leiden) or Switzerland (Geneva)
Job Description
As one of the world’s largest healthcare companies, we are driven to foster better health for more
people in more places. While the world has made significant progress in providing improved
healthcare, major gaps remain, and bolder, smarter approaches are needed to overcome the drastic
inequity in access to care—now.
Through a dedicated global public health (GPH) organization that
combines research and development, global access strategies and programs, and local operations, we
are putting the world’s most vulnerable and underserved at the heart of everything we do—measuring
our success in lives improved.
As a team of innovators, we are committed to pioneering and sustainably
delivering meaningful and transformational products. Working with global and local partners, we will
ensure equitable access to these critical solutions that save lives, cure patients, and prevent disease
for those most in need. Upholding the rich heritage of Johnson & Johnson, we are taking on the
toughest challenges, and, ultimately, we hope to do our part to close the gap of inequity and pave the
way to a healthier future for the world’s most vulnerable and underserved populations.
Janssen/ GPH regulatory
Position Summary & Responsibilities
We are looking for an exceptional Associate Director Regulatory Affairs EMEA GPH Liaison (Vaccine
Programs) to support the JnJ Global Public Health Organization (GPH) who will drive the regulatory
strategy and execution plans for the GPH vaccines portfolio, including our COVID-19 and Ebola Vaccine
programs, across Africa. This role should prioritise and optimize the regulatory strategy to register
vaccines in Africa, identify policy issues to shape the Regulatory Affairs landscape in Africa and
effectively interact with relevant external stakeholders like the African Vaccines Regulatory Forum
(AVAREF), WHO AFRO and National Regulatory Authorities. The person will be responsible for working
with internal Global Regulatory Affairs (GRA) members and other functions at regional level and
working with LOC RA teams and LTRs in the in-scope markets to ensure timely submission and
regulatory compliance. May have indirect reports in markets
The Associate Director Regulatory Affairs EMEA GPH Liaison (Vaccine Programs) is a member of the
Global Regulatory Affairs organization. The position resides in the EMEA EM region and is responsible
for working with the local regulatory affairs teams, Global Regulatory Team and other teams (e.g.
Strategic Implementation Leader) to define, align and implement the regional regulatory strategy for
GPH Markets for assigned products. The position is accountable for leading and providing strategic
regional and local input into the global regulatory strategy (which includes identifying regional and
local regulatory requirements for efficient product registration, lifecycle management activities and
clinical trials within the region). Support to regional or local tender applications as appropriate.
This role will work closely and under the guidance with the WHO liaison (GRL) to discuss regional
regulatory affairs matters with the WHO Headquarters as appropriate. This position will be a full
member of the appropriate Access Strategy and Implementation team and a full member of the
regional launch team. It will liaise with the Head of Regulatory Affairs EM/ GPH and the WHO liaison
(GRL), and inter alia, with the LOCs and GRTs to develop and facilitate an efficient regulatory strategy
to achieve prompt submissions and earliest approvals for Janssen GPH products. The position is
responsible for the consolidation of the regional strategy and prioritisation of countries aligned with
GPH objectives.
The position will ensure regional and local affiliates (LOCs/ LTRs) are supplied with timely responses
to Health Authority enquiries; as well as regulatory support to GPH Africa Operations team. Position
will ensure adequate preparation for health authority meetings and may attend and provide
presentations to health authorities, if appropriate.
The Associate Director Regulatory Affairs EMEA GPH Liaison (Vaccine Programs) develops the
regulatory strategy for the in-scope GPH markets in Africa, aligning this with the overall GPH Access
Strategy and Implementation whilst liaising with regional Therapeutic Area (TA teams within GRA for
the respective programs as / if needed, hence will be required to participate as team members in the
various cross functional project teams within the global/ Africa GPH operations as the Regulatory
Affairs representative and also in GRA regional TA meetings.
Special focus on vaccine programs
For
discovery to delivery for said portfolio as per direction of regional and global teams.
and innovative regulatory strategies to facilitate and expedite vaccine development
and optimize the probability of success for regulatory approval at the originator and
destination countries and WHO Prequalification (PQ) for the markets in scope under
The Guidance Of The GRL WHO Liaison.
consultants) as needed to facilitate timely clinical trial authorizations and vaccine
registrations as and if required.
GRL WHO liaison for timely WHO PQ and pathways for Low- and Middle-Income
Countries (LMIC) registration in EMEA region (focus Africa).
systems initiatives aimed at facilitating registration and access in LMIC in EMEA region
(e.g. The WHO Collaborative Registration Procedure And Regional Regulatory
harmonization initiatives).
teams, presentations to internal and external customers, leadership briefings, etc.
ensure equitable access for Covid -19 vaccine across Africa with special focus on SSA.
Teams Especially Partnering With The WHO Liaison.
with grantees and partners in the field, for example AVAREF and WHOAFRO.
Strategic and tactical input in development, post-approval and Life cycle management for
GPH Portfolio in Africa
EMEA GPH markets ensuring alignment with the overall global and regional GPH strategies.
regulatory issues, project-specific regulatory issues, and issues related to regional regulatory
environment
country specific requirements changes are adequately captured in relevant databases (e.g.
and tactics in support of the global development and life-cycle management plan ensuring
utmost regulatory compliance.
intelligence and therapeutic area
Africa
provide access to vaccines in the region
the implications of regional regulatory strategy for labelling
comments into development and life-cycle management plan (e.g. WHO discussions,
regional EM HA discussions)
are understood, to aid building business in new markets in a complaint manner
Liaison with Regulatory Agencies and Local Operating Companies
local Regulatory Agency meetings
regional strategy and timelines
activities, requiring global / regional alignment.
Input in document and process development
and submission
determining content and review of documents
and support labelling statements as appropriate
Clinical Trial Applications (CTA)
registration strategies to support registration, reimbursement and competitive labelling
CTA
timelines
Marketing Authorization Application (MAA)
a complaint manner.
to the LOCs according to the strategic implementation plan
Qualifications
Job Requirements
Education And Experience
Leadership & Culture
Skills
Knowledge
Internal & External Contacts
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Please, refer to the job board KALETA.co as your source while applying for this job
Tagged as: Johnson & Johnson, Vaccine
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