Total 2 job vacancies by Global Antibiotic R&D Partnership (GARDP)

The regulatory affairs consultant for Asia Pacific will provide regulatory strategic and tactical leadership for drug development projects, including health authority interactions, regulatory submissions, clinical trial applications and other regulatory requirements in line with GARDP objectives, timelines and budgets. This role requires a deep understanding of local regulatory requirements and the ability to navigate complex regulatory environments.

Tasks and Responsibilities

• Preparation and submission of local Clinical Trial Application to regulatory authorities and IRB/IEC as soon as possible to obtain all necessary regulatory approvals within defined timelines.
• Primary responsible person for communication with RA and ECs during the clinical trial lifecycle.
• Manage and support the clinical research organization responsible for clinical trial applications for NEOSEP Part 2 to regulatory authorities and ethic committees in the Asian countries (Bangladesh, Vietnam, Malaysia, India and Pakistan).
• Complete regulatory intelligence on regulatory pathways for registration of old antibiotics in the Asian countries
• Manage and support the sublicensee responsible for the STI product registration in Asian countries.
• Assess and communicate the impact of relevant regulatory policies, regulations, country legislation in relation to the GARDP product portfolio.
• Compile and assesses regulatory intelligence to assist in the development of local, regional regulatory strategies.
• Develop new regulatory affairs policies, processes, and standard operating procedures for the GARDP RA system.
• Support the articulation of the regulatory requirements for the early access programs.
• Attend project team meetings (in absence of the HEAD of RA) to provide technical guidance and support on regulatory activities in Asia Pacific.
• Organize and man
• Mangement of regulatory documents and records for the GARDP products.

Point of Contacts and Interactions

The main point of contact is the Head of Regulatory Affairs of GARDP. He / She works closely with the GARDP programmes & project teams.

Position Requirements:

Knowledge and Skills:

• Good understanding of the regulations, directives and guidance supporting clinical Research and Development.
• Strong working experience with a variety of regulatory authorities is required, with real first-hand experience of managing clinical trial applications and product registrations with different regulatory authorities.
• Experience with regulatory authorities, Ethic Committees and Ministry of Health for the Asia Pacific countries.
• Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision.
• Strong ownership and oversight skills.
• Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach. Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Strong software and computer skills, including MS Office applications.

Education and Experience:

• Bachelor’s degree in pharmacy / science or Master’s degree.
• Minimum 5 years’ experience in Regulatory Affairs for Asia Pacific countries and clinical trial activities related to medicines is mandatory.

To Apply:

• Please submit your application using the online form
• Consultant Tax Registration number
• Deadline for applications: 8.12.2024
• From 1st of January to 31st of December
• Activity rate : 80%
• Please note that only shortlisted candidates will be contacted.

Overall Purpose:

This position will be responsible for partnerships relating to the delivery and commercialization of GARDP products in the South Asia Region. This includes the management of the relationship with partner(s), and ensuring the wellbeing of partnerships. Such partners include for example manufacturers, market authorization holders, distributors, pricing authorities etc. This position will also be responsible for managing GARDP's business intelligence activities for all products, which is necessary to effectively monitor the activity reports of the partner(s).

The Regional Product Delivery, Manager will work with GARDP staff across different functional teams

Contribution

The Regional Product Delivery Manager (PDM) will implement partnership activities to ensure delivery of products at the national/regional level. His/her main role will be around identifying, evaluating, engaging with and managing partners, supporting regional / local market shaping activities and monitoring delivery activities of partners The PDM will also be propositional to the Products Delivery & Management Leader, so as to capture and integrate into the delivery strategy regional constraints and particularities.

Role responsibilities

Implement partnership activities to ensure delivery of products at the national/regional level (in coordination with the GARDP Product Team and the GARDP Global Access Team):

-   Map the landscape of stakeholders necessary to ensure proper import and delivery of GARDP’s portfolio product (including distributors, pharmaceutical companies, etc )  in the selected  priority  countries in the SA region

-   Create, maintain and strengthen a network of potential partners,

-   Develop a “business case” to support any internal decisions on partnerships and selection of the right partner(s),

-   Support negotiation with the partners,

-   Support the development of the required contracts that will seek to secure the availability of products

Alliance management of national/regional partner(s) – Manufacturer(s) and Commercial Partner(s)

-   Clarify the scope of responsibilities of the partner(s) with the support of the Head Products Delivery

-   Build strong relationships with partner(s) through transparency, flexibility and mutual respect

-   Manage the execution of the contracts with partners / guarantee that contractual engagement are respected,

-   Develop the appropriate tools to ensure a good reporting (KPIs, frequency, …)

-   Monitor and report on all activities pertaining to product import and delivery (follow the medical communication, gather data on distribution of GARDP products, monitor the sales, regional volume forecasting and updates on market & public)

-   Organize internal quarterly reporting session relevant staff in the GARDP network to assess the collaboration with the partner(s)

-   Support GARDP BD team towards regional volume forecasting.

Manage GARDP Global Market Intelligence activities

-   Support the creation of market intelligence activities and ensure their implementation within GARDP

-   Manage global market understanding activities

-   Understand global and regional business dynamics and the competitive market landscape relevant to GARDP programs (pricing, positioning, business strategy, …)

-   Gather key market and business insights to capture the reality of the markets for all GARDP products,

-   Work with the Global Access team, and the BD team on market shaping activities (quantification of the market to follow future discussion with relevant partners)

-   Represent GARDP at regional conferences / events for identification of new partners/ relationship management with existing partners.

Reporting lines

Direct line – Product Delivery Head

Interactions

Internal: GARDP BD, Global access, R&D, Legal, External Affairs, Communications teams

External: Pharmaceutical partners, CDMO, Distributors, pricing authorities, tender authorities and other partners needed to implement GARDP strategy

Skills and Attributes

• Entrepreneurial mindset and excellent organizational skills;

• Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines

• Strong communication skills in multicultural, multi-lingual environments;

• Strong analytical skills;

• Proven ability to work effectively in a team environment and matrix structure;

• Ability to clearly communicate and work effectively in collaboration with diverse groups of people
• Clear and systematic thinking that demonstrates good judgment and problem solving competencies
• Well organized and structured
• Strong ability to provide high level support in project/program delivery
• Strong ability to manage medium/large projects with budget management
• Strategic thinking and leadership abilities as defined in the Leadership competency model
• Strong management, negotiation, and advocacy skills
• Has autonomy for taking actions and decisions
• Strong ability to interact with external stakeholders

Experience

• Minimum 6 years' relevant experience in which at least 4 years at Senior Officer level
• Proven ability to work effectively in a team environment and matrix structure
• Experience of working in the pharmaceutical industry, highly desirable
• Knowledge of the pharmaceutical landscape in India/South Asia, highly desirable
• Previous Project Management experience, desirable
• Familiarity with manufacturing and commercialization, desirable

Education

• Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level
• Master's degree in Pharmacy, Marketing/Market Research (or other relevant degrees)

Other Requirements

• Fluency in English
• Proficiency in local languages desirable
• Very good knowledge of Microsoft Suite
• Proficiency in Excel & Salesforce

To apply

• Please submit your application using the online form
• Accepting applications until March 7th 2024 at 5pm CET
• All applications will be reviewed after closing date