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Cargo: Regulatory Policy Lead

As Regulatory Policy Lead you will be responsible for leading LATAM Regulatory Policy activities of the PTR (Pharma Technical Regulatory) Policy Team, developing and executing a regional roadmap for regulatory convergence in the best and most sustainable interest of Roche. This function will ensure alignment and regulatory stakeholder engagement within PT (Pharma Technical), PD (Pharma Development), Government Affairs, DRAs (Affiliates Regulatory Affairs) in the region as well as external interest groups according to PTR Policy priorities.

 

Main Responsibilities:

  • Establish a strong partnership and networks with internal (i.e. PDR, Medical, Access, Gov. Affairs, PTQ external collaboration) and external stakeholders;
  • Ensure the development, execution, reporting and communication of the global/regional regulatory policy roadmap;
  • Provide regulatory policy support for specified affiliates and specified policy topics;
  • Lead strong cross-functional teams to identify and conduct external outreach activities on policy priority topics;
  • Maintain an overview of global/regional regulatory policy topics of high relevance and identify and drive opportunities of external engagement for Roche;
  • Actively participate in key conferences with relevant regulatory stakeholders addressing Roche key priorities;
  • Drive discussions at the local, regional and/or global associations (e.g. EFPIA, FIFARMA, BIO, PhRMA, IFPMA...) and/or governmental organizations (e.g. APEC, PANDRH) in line with the Roche positions by striving for leadership in respective working groups;
  • Support regulatory draft regulatory guideline review and consolidation, whenever possible in alignment with global commenting process;
  • Implement or provide affiliate support for internal trainings on business critical regulatory policy topics. Ensure cross-regional/global exchange on the evolution of the regulatory policy landscape and best practices;
  • Lead the development of specified Global Regulatory Policy positions in close collaboration with Subject Matter Experts and other regional policy leads.

 

In order to be successful as Regulatory Policy Lead, it is necessary:

  • Advanced degree in life science or natural science e.g. Analytical, Biochemistry, Biology, Pharmacy or other similar regulatory related areas; MBA is an advantage;
  • Strong team player and communicator and Excellent oral and written communication skills;
  • Proven effectiveness in operating in multi-cultural environment;  
  • Solid work experience in Regulatory, Quality, Process Development or Manufacturing in the biopharmaceutical industry area;
  • Proven ability to build and maintain strong relationships with global health authorities;  
  • Previous Experience in Regulatory (Industry or Agency) is preferred;
  • Excellent collaboration skills, and demonstrated ability to work collaboratively in international regulatory and/or industry/scientific associations;
  • Proven ability to develop innovative technical regulatory strategies, and key positions on topics of external relevance;
  • Recognized expert in relevant CMC technical/regulatory area with established external credibility as thought leader;
  • Fluent Portuguese, advanced English and Spanish;
  • Ability to travel up to 30%.

 

 Para se candidatar a essa vaga acesse o link https://www.roche.com/careers/jobs/jobsearch/job.htm?id=E-201901-102140&locale=de&title=Regulatory+Policy+Lead