Regulatory Consultant

Follow us@ngobox

About the Organization

The Drugs for Neglected Diseases initiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases affecting millions of the world’s poorest people.

Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients’ needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients.

Job Description

The Regulatory Department provides strategic regulatory guidance throughout the different stages of development, managing global regulatory activities for the DNDi portfolio in collaboration with the project teams to ensure timely availability to the patients where they need treatments, and interacts effectively with several partners and stakeholders to ensure that DNDi’s mission is fully reflected in the agreed regulatory strategy.

The Regulatory Consultant provides support to achieve Regulatory Department’s goals.

Job Responsibilities

• The Regulatory Consultant provides effective operational and regulatory support to the Regulatory Sciences department as well as to the DNDi’s regional offices in Asia (with a focus on India) for assigned regulatory submissions, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives-related activities.
• Coordinates and prepares high quality submissions of regulatory dossiers for assigned products to Health Authorities in time,
• Provide regulatory support and advice to disease and regional clinical operations on clinical trial requirements and dossier requirements for national, regional and global submissions,
• Tracks and communicates regulatory relevant activities, approvals, deadlines, events and KPIs for assigned products. Maintains country specific information in the regulatory-relevant databases and archives. Ensures traceability and integrity of the regulatory record by accurate and timely data management in regulatory compliance databases for assigned products in close collaboration with the Regulatory Sciences lead,
• Establishes and maintains close professional relationship to Asian Health Authorities, and other internal/external stakeholders and institutions, as appropriate,
• Support the preparatory activities including briefing package preparation for interactions with regulatory authorities and facilitates face to face meetings,
• Maintain awareness of external regulatory environment, new guidelines and legislation with a focus on Asia.

The above list of responsibilities is not exhaustive, and you may be required to undertake other responsibilities appropriate to your grade. This job description may be subject to review.

Education Qualification/Required Skills & Experience

• Strong communication skills in multicultural, multi-lingual environments, with ability to work in a matrix environment,
• Proactive personality,
• Fast and flexible, focused on timely delivery and stretch targets,
• Ability to plan and priorities workload,
• Open to change and willingness to learn,
• Clear and systematic thinking that demonstrates good judgment and problem-solving competencies,
• Risk taken approach.

Experience

• Experience of regulatory procedures and legislation related to drug development and clinical trial applications. From 5 to 10 years of global or local experience preferred in this field,
• Experience of registration in EU and US will be an advantage
• Experience in regulatory registration of NCEs, clinical trial applications or clinical medical writing is desirable,
• Knowledge of India and Asia Regulatory environment of Drug development & registration; understanding of regulations, laws, guidelines and requirements,
• Experience to coordinate projects, monitoring milestones, to achieve objectives under required tight timelines,
• Ability to work effectively in a multinational virtual team and to interact with internal/external stakeholders (partners, consultants etc),
• Technical and scientific writing/review skills (briefing books, protocol/report review etc).

Education

• Minimum bachelor’s degree in science/ scientist
• Minimum of 5 years pharmaceutical experience and/or a minimum of 4 years of regulatory experience.

Other requirements

• Fluency in English as a business language.

Please submit your application using the online form

Deadline for application: accepting applications until 18 October 2024

For more information please check the Link

Be A Part of Asia’s Largest CSR & Sustainability Forum- India CSR Summit & ESG Forum 2024 | 16th*, 17th & 18th October 2024

Tags Jobs in Delhi Jobs in New Delhi Jobs in Environment Jobs in Consultant