Purpose of the position
This position supports the Regulatory Affairs team which 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.
Specific Job Responsibilities
Provide regulatory support and advice to disease and regional clinical operations on clinical trial requirements and dossier requirements for national and regional submissions.
Monitor progress of assigned regulatory projects/deliverables within established timeframes- Ensure appropriate filing & archiving.
Participate in the review of non-clinical and clinical study protocols to ensure alignment with global regulatory requirements.
Support the preparatory activities including briefing package writing for interactions with regulatory authorities and lead or co-lead face to face meetings.
Interact as appropriate with internal and external stakeholders to optimize access timing of new medicines for patients.
Support regulatory affairs unit and DNDi processes.
May support Head of Regulatory Affairs in other delegated tasks (not specific to Africa)
Reporting line
S/He 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
Fluency in English and French
Strong knowledge of African Regulatory environment of Drug development & registration; understanding of regulations, laws, guidelines, and requirements.
Strong ability to coordinate projects, monitoring milestones, to achieve objectives under required tight timelines.
Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
Strong ability to travel and work in the field.
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/program delivery.
Strong management, negotiation, and advocacy skills
Strong autonomy as the only regulatory expert locally
Ability to work effectively in a multinational virtual team and to interact with internal/external stakeholders (partners, consultants etc)
Technical writing/review skills (briefing books, protocol/report review etc)
Experience
Minimum 7 years’ relevant experience
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 in experience to reach Master level in relevant field.
Other Requirements
Travel and field work up to 50%
Apply via :
dndi.org
