Regulatory Affairs Consultant

Purpose of the position

The Regulatory Affairs Consultant acts as an internal regulatory expert, advising and supporting the assigned disease teams, providing strategic regulatory guidance throughout the different stages of development, managing regulatory activities for the DNDi portfolio in the Region of its performance in collaboration with the teams design to ensure timely availability for patients where they need treatment and interact effectively with various partners and stakeholders to ensure that DNDi’s mission is fully reflected in the agreed regulatory strategy.

She/he acts globally with a main (not only) focus on Latin America.

Tasks and responsibilities

The Consultant will hold the following responsibilities and accomplish the following tasks:

• 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 LATAM )
  Reporting line

• DNDi reference person shall be Head of regulatory affairs

  Job Requirements
  Skills and Attributes

• 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

  R& D Technical Skills

• Strong knowledge of Latin America 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 Latin America and other countries. Experience with FDA or other stringent regulatory authorities will be an advantage

• 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 writing/review skills (briefing books, protocol/report review etc)

  Experience

• Minimum 7 years’ relevant experience

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

• 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. Education in regulatory affairs is desirable.

  Other Requirements

• Fluency in English and Spanish

Other information

• Status: Consultancy ( Until December/2021 – possibly renewal)