Regulatory Sciences Consultant

Purpose of the position
The Regulatory Sciences 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 in order 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 Sciences consultant provides support to achieve Regulatory Sciences department goals.
Specific job responsibilities

Project Regulatory lead

Accountable for managing projects and delivering quality output through expert services Coordinates regulatory activities in core team

Provides timely regulatory support and advice to disease and regional clinical operations on clinical trial requirements and dossier requirements for national and regional submissions

Monitors progress of assigned regulatory projects/deliverables within established timeframes- Ensures appropriate filing & archiving- S/he ensures timely update in the regulatory data base ( sharepoint, veeva…)

Develops strategic plans and regulatory risk assessments and create innovative regulatory solutions

Pro actively addresses issues, gaps, options and trade-offs

Provides timely regulatory support and advice to disease and regional clinical operations on clinical trial requirements and dossier requirements for national and regional submissions – Participates in the review of non-clinical and clinical study protocols to ensure alignment with global regulatory requirements and provides high level output

Interactions with Health authorities

Develops global regulatory strategy and plans for health authorities 

Supports the preparatory activities including briefing package writing for interactions with regulatory authorities and lead or co-lead face to face meetings

Regulatory excellence and compliance with regulatory and DNDI policies

Drives proactively to  ensure regulatory excellence

Prepares and update SOPs

Conducts training and education to increase regulatory compliance at DNDi

Timely experience shared with regulatory team

Regulatory intelligence and policy

Responsible for the regulatory watch of African Countries (east and southern Africa in particular)  in order to identify any change having an impact on the product development and /or leading to new regulatory activities

Represents DNDi at KAPI discussions or with any stakeholders by 1) consolidating lists of questions for DNDi 2) getting feedback and 3) providing meeting notes within 4 days

Analyses, formulates and presents recommendations related to regional regulatory affairs to advice teams

Regulatory Sciences Team support

May support Head of Regulatory Affairs in other delegated tasks (not specific to  Africa)

Actively supports the objectives and activities of the regulatory team

Ensures compliance and adherence regulatory and DNDi standards.

Reporting line

The Regulatory Sciences Consultant reports to the Head of Regulatory Affairs based in Geneva.
Close working relationship with the assigned disease and clinical operation regional teams to deliver new treatments for neglected diseases in the DNDi portfolio.

Job requirements
Skills and attributes

Strong knowledge of African Regulatory environment of Drug development & registration; understanding of regulations, laws, guidelines and requirements
Experience to support local clinical trials from submission to studies completion
Experience of interacting with different regulatory authorities in Africa and other countries. Experience with stringent regulatory authorities (EMA, FDA…) and joined regional initiatives will be an advantage
Experience to coordinate projects, monitoring milestones, to achieve objectives under ambitious timelines
Ability to work effectively in a multicultural and virtual team and to interact with internal/external stakeholders (partners, consultants etc)
Strong technical writing/review skills (briefing books, protocol/report review etc)
Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
Can do attitude -makes things happen
Open to change and willingness to learn
Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
Strong communication skills in multicultural, multi-lingual environments
Well organized and structured
Strong analytical skills
Strong ability to provide high level support in project/programme delivery
Strong management, negotiation, and advocacy skills
Strong autonomy as the only regulatory expert locally
Fluency in English
Fluency in French is an added advantage

Experience

Minimum 15 years’ relevant experience
Proven ability to work effectively in a team environment and matrix structure, managing complex/virtual networks and partners.
Experience of interacting with different regulatory authorities in Africa and other countries.
Experience with stringent regulatory authorities (EMA, FDA…) and joined regional initiatives will be an advantage.
Proven experience in offering regulatory support to clinical trials.
Experience of working in public and private sector is desirable.

Education

Advanced post graduate degree or graduate degree with equivalent experience to reach Master level in relevant   field. Education in regulatory affairs is desirable.

Other requirements

Status: Part time consultancy
Travel and field work up to 50%

Apply via :

dndi.my.salesforce-sites.com