Regulatory Affairs Director

hace 24 horas

Ciudad de México, Ciudad de México Pharmanovia A tiempo completo
About the Role:

We are seeking a highly experienced Regulatory Affairs professional to lead the establishment of Regulatory Affairs management in the LATAM region for Pharmanovia, a dynamic and fast-growing international pharmaceutical company.

As Regulatory Affairs Manager, you will be responsible for all aspects of the LATAM Regulatory Strategy, supporting the growth of the pipeline in LATAM. You will work closely with the Global Regulatory Lead, Regulatory Product Leads, Scientific Affairs, and General Manager in cross-functional project teams to ensure LATAM growth strategies are realised.

The successful candidate will have a proven track record of CTA/NDA and associated strategy in LATAM, with a strong understanding of the regulatory infrastructure required for the marketing and distribution of pharmaceutical products. They will also have excellent IT skills, including MS Word, Excel, Project, PowerPoint, and Outlook.

The ideal candidate will be a master's degree holder in pharmacy, medicine, or chemical sciences, with a minimum of 5 years of regulatory affairs experience within a multinational pharmaceutical company. They will have strong knowledge of local regulatory frameworks and guidelines, as well as expertise in writing scientific and technical documents.

The Regulatory Affairs Department at Pharmanovia has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

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 submissions, 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
  • Serve as a critical member of the Regulatory Affairs team providing LATAM-focused product development strategies and the registration of foreign-developed products
  • 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:
  • 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 frameworks 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.

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