Posted on :
8 Feb, 2021
8 Feb, 2021
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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
Job Title: Associate Director Regulatory Affairs
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. Positionwill 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
• The Regulatory Affairs Liaison for GPH will support GPH vaccines portfolio and be responsible for:
o Providing internal engagement teams with vaccine specific regulatory support from discovery to delivery for said portfolio as per direction of regional and global teams.
o Advising and working closely with the local engagement teams to align on efficient 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.
o Providing local team with support on strategy, tactics, and external resources (CROs, consultants) as needed to facilitate timely clinical trial authorizations and vaccine registrations as and if required.
o Advising local engagement teams on optimal strategies and tactics for in support of GRL WHO liaison for timely WHO PQ and pathways for Low- and Middle-Income Countries (LMIC) registration in EMEA region (focus Africa).
o Contribute to development of strategies for leveraging global health regulatory 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).
o Determine scope and nature of regulatory technical contribution to local engagement teams, presentations to internal and external customers, leadership briefings, etc.
o Recommend regulatory strategic pathway for emergency and long-term filing to ensure equitable access for Covid -19 vaccine across Africa with special focus on SSA.
o Work according to internal quality requirements and in line with established GRA teams especially partnering with the WHO liaison.
•This role is responsible for high quality interactions and clear and consistent communications 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
Liaison with Regulatory Agencies and Local Operating Companies
Input in document and process development
Clinical Trial Applications (CTA)
Marketing Authorization Application (MAA)
Education and experience
Leadership & Culture
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.