Director Regulatory Affairs LATAM

Regulatory Affairs US Field Based


Description

Summary:  

Due to the exciting growth at Seagen, we are expanding our Regulatory team to include a new Director, Regulatory Affairs LATAM. This position will report into the Executive Director, EU and ROW Regulatory Affairs and will be a part of the team that provides strategic direction for affiliate and distributor regions. This role will have the opportunity to provide strategic input for all LATAM Regulatory matters, collaborate with distributor partners, and contribute to getting marketed products available to patients in need. Ideally, we are seeking candidates that are located on the East Coast of the US to better collaborate with the distributor partner and between teams located in the US and Europe.  

Principal Responsibilities: 

  • Develop and lead LATAM regional regulatory strategy, in collaboration with Project Teams, Global Regulatory Teams (GRTs), and distribution partner to shape optimal global regulatory strategies for established and development products
  • Liaise with distribution partner to ensure that the pharmaceutical products distributed in the LATAM countries meet the local regulatory requirements and support the local commercial strategy
  • Serve as the LATAM Regional Lead on the GRTs, provide strategic input for all LATAM Regulatory Affairs matters, including the seeking of Scientific Advice, MAA submissions, CTAs, other relevant regulatory procedures, in collaboration with the distribution partner
  • Define and execute strategies for regulatory maintenance submissions (amendments, notifications, variations, renewals, annual updates) for drug products in the region in collaboration with the distribution partner 
  • Manage emerging issues (e.g. new safety or quality finding) and associated risk communications to stakeholders
  • Develop and maintain highly collaborative relationship with the distribution partner for the LATAM region
  • In partnership with other regulatory staff, maintain and expand current knowledge of regional regulatory requirements and precedents, interpret changes, that may affect the clinical development and commercialization of company products, analyze gaps and conduct impact assessment, and participate/lead implementation into systems/processes 
  • Provide trainings/briefings on specific LATAM regulatory topics to project teams and other stakeholders to ensure effective product development, registration, and compliance with the region’s regulatory requirements 
  • Actively contribute to improving critical departmental processes and initiatives to enhance the internal work environment 
  • Performs other duties as required 

Required Qualifications: 

  • PharmD, PhD, Masters or Bachelors degree in life sciences 
  • Minimum of 8 years of Regulatory experience, with at least 5 years in a similar LATAM-based strategic role 
  • Expert knowledge of LATAM regulatory requirements and environment 
  • Direct experience of regulatory submissions and agency interactions in a major LATAM country is an advantage 
  • Experience of overseeing vendor services and cross-functional collaborations
  • Thorough knowledge of drug development and life-cycle maintenance processes 
  • Familiarity with FDA IND/NDA/BLA and European regulatory procedures 
  • Fluent in English (spoken and written), fluent in Portuguese and/or Spanish 

Preferred Qualifications: 

  • Line management experience
  • Regulatory project management experience 

Preferred Location: 

  • East Coast of the US  

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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