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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
- Work with the RA EM/GPH Head, WHO Liaison, GRL, relevant TA team, Access Strategy and
- Implementation Team, regional launch team and LOCs to develop the regulatory strategy for EMEA GPH markets ensuring alignment with the overall global and regional GPH strategies.
- Advise the Project Team, EMEA lead and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory environment
- Drive understanding of regional guidance and national regulatory requirements, ensure country specific requirements changes are adequately captured in relevant databases (e.g.
- CMC & RIACS)
- Develop and ensure effective implementation of regional and national regulatory strategy and tactics in support of the global development and life-cycle management plan ensuring utmost regulatory compliance.
- Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
- Provide input to the Africa regulatory policy team to shape the regulatory environment in Africa
- Develop and maintain the understanding of the external stakeholders and environment to provide access to vaccines in the region
- Provide input for developing and updating the Target label(s) based on an understanding of the implications of regional regulatory strategy for labelling
- Where appropriate ensure implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan (e.g. WHO discussions, regional EM HA discussions)
- Liaison with GPH teams to ensure GPH strategic business needs, and resource requirements are understood, to aid building business in new markets in a complaint manner
Liaison with Regulatory Agencies and Local Operating Companies
- Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate
- Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings
- Determine timing and strategy for Regulatory Agency meetings and scientific advice
- Liaise with LOC & RSI to ensure briefing books and documents available and aligned to regional strategy and timelines
- Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed
- Provide support for negotiations with Regulatory Agencies with respect to labelling, or other activities, requiring global / regional alignment.
Input in document and process development
- Advise team on required documents and processes to support Regulatory Agency contacts and submission
- Plan and develop briefing documents for meetings with Regulatory Agencies, including determining content and review of documents
- Provide input to and review submission documents to ensure that they are fit for purpose and support labelling statements as appropriate
- Define and facilitate the generation of appropriate data-driven (regional/local) responses to
- Regulatory Agency questions, enable LOC submission thereof.
Clinical Trial Applications (CTA)
- As needed, provide intel to ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labelling
- As needed, advise team on required documents and submission strategies in preparation of CTA
- As needed, ensure CTA submission packages are complete and available according to agreed
Marketing Authorization Application (MAA)
- Provide regulatory support throughout registration process
- Provide regulatory support throughout life-cycle management and make sure this is done in a complaint manner.
- Oversee RSI implementation of country-specific submission requirements are made available to the LOCs according to the strategic implementation plan
Education and experience
- University degree – medical or paramedical (pharmacy, biology, veterinary etc.)
- At least 10 + years of experience in Regulatory Affairs of which at least 5+ years in Africa.
- Specific experience in vaccines and in working with Public Health stakeholders such as WHO, AVAREF is highly desirable.
- Experience with vaccine development, registration, and regulatory life-cycle management and tender business, ideally with experience in LMICs. Some experience with vaccines is key.
- Knowledge of major industrialized country regulatory processes and considerations, FDA, EMA, and WHO PQ. Experience with other developed and developing nations (e.g. national regulatory authorities in the EU, Canada, Australia, India, China, and South Africa) is a plus
- Experience in working in project teams and/or a matrix organization
- Experience in shaping regulatory environment via policy &/or trade associations is an advantage
Leadership & Culture
- We are guided by our Credo at the centre of everything we do. We believe that working with our leadership imperatives Connect, Shape and Grow is crucial for our success.
- Technical excellence, common appreciation of the problem at hand, humility, negotiation skills, listening, bottom up approach to collaboration, cultural sensitivity, firmness
- Able to navigate in a VUCA (volatility, uncertainty, complexity and ambiguity) environment.
- Can deal with highly complex situations; recommendations are made only after extensive research and consultation with others
- Demonstrated ability to lead people and teams to effectively achieve clear, yet complex goals and objectives.
- Strong experience in working effectively with senior decision makers as it pertains to strategy development and operations.
- Experience developing and handling strong partnerships and relationships both inside and outside the organization, handling conflicts, and building consensus.
- Ability to lead and influence data-driven strategy planning and implementation.
- Effective collaborator and experience working in a matrix environment (i.e., ability to influence without formal authority).
- Adept at project management; including critical path thinking, detail orientation, setting priorities, and planning.
- Broad knowledge of global health issues, vaccine development processes and regulatory requirements and procedures; at both global and national levels is helpful.
- High level of cultural competence
- Excellent knowledge of English
- Knowledge of the applicable therapeutic area
- In depth knowledge of the regulatory environment, guidelines and practice in Africa/ LMIC/Emerging Markets
Internal & External Contacts:
- Internally with GRA teams and Cross functional leadership/ project teams in the GPH space
- Externally with Heads and leadership of National Regulatory Agencies, WHO Advocacy Groups and Directors, Donor groups Directors, Pharma industry senior leadership, African Union agencies Director/Commissioner levels, etc.
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.