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Regulatory Affairs Director

hace 2 meses

Xico, México Pharmanovia A tiempo completo
About the Role

We are seeking a highly skilled Regulatory Affairs Manager to lead the establishment of Regulatory Affairs management in the LATAM region. As a key member of our team, you will be responsible for all aspects of the LATAM Regulatory Strategy, supporting the growth of the pipeline in LATAM.

Key Responsibilities
  • Lead Pharmanovia's Regional operations strategically aligned to growth plans in LATAM
  • Establish regional infrastructure and ensure regulatory compliance with the national competent authority legislation for the marketing and distribution of Pharmanovia's products
  • Lead the successful launch of new product development by ensuring the timely roll out of new applications and post approval changes regionally
  • Establish regulatory strategies and develop submissions for CTAs, CTA exemptions, NDA submission, pre-NDA meetings, life-cycle management and labelling management
  • Regional regulatory lead representing due diligence assessments and development opportunities
  • Ensure planning and optimal organisation of regional regulatory activities
  • Drive growth opportunities in LATAM through strategic planning and in-depth understanding of the regulatory framework in LATAM
  • Ensure full readiness and compliance of the local entity and all related activities for products commercialization
  • Lead interactions and submissions with the COPEFRIS and related Health Authorities for LATAM markets
  • Monitor, identify and communicate regulatory environmental trends and regulation development which would influence Pharmanovia's growth opportunities
About You
  • Candidates with at least 5 years of regulatory affairs experience within a multinational pharmaceutical company are likely to have the skills required to be successful in this role
  • Master's degree or above in pharmacy, medicine or chemical sciences
  • Great IT skills including MS Word, Excel, Project, PowerPoint, and Outlook
  • Proven record and recent experience of CTA/NDA and associated strategy in LATAM
  • Good understanding of the regulatory infrastructure required for the marketing and distribution of pharmaceutical products
  • Strong knowledge of local regulatory framework and guidelines
  • Must be able to independently present complex global regulatory strategies internally and to Pharmanovia's partners
  • Expertise in writing scientific and technical documents, and strong attention to detail with proofreading materials
  • Overall global expertise, professional gravitas and strong influence skills and will display personal and professional maturity
  • Data driven in decision making with the ability to analyse complex situations, focus on the key issues and communicate within the team and upwards with clarity and concisely
  • Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
  • Strong networking, planning and organisational skills with a demonstrated capability to manage complex projects with short timelines
  • Ability to work successfully within cross-functional teams
  • Excellent professional communication skills, both written and verbal
  • Fluency in both Spanish and English languages required
What We Offer
  • We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working