Prothena

Sr. Manager, Regulatory Affairs

Job Locations US-CA-South San Francisco
Job ID
2018-1276
Category
Research & Development

Overview

Reporting to the Director of Regulatory Affairs, and in accordance with the goals of the company, and applicable regulations, standards, established procedures and planned objectives, the Senior Manager of Regulatory Affairs will be responsible for developing regulatory strategies, planning, managing and executing regulatory activities for investigational drug products in the US.

Responsibilities

  • Work with the Director of Regulatory Affairs and global regulatory team to develop US regulatory strategies and support the development of global regulatory strategies for assigned programs
  • Provide strategic input to the global Regulatory team for US Regulatory Affairs matters, including the seeking of Scientific Advice, across programs
  • Define and execute strategies for IND/BLA regulatory submissions and required maintenance (amendments, notifications, supplements, renewals, annual updates) for assigned programs in the US; as needed, work with regulatory affairs consultants/contractors, submit regulatory documentation and act as primary contact with the FDA to achieve objectives
  • Manage customization of IND dossiers, and organize submission and registration of drug products in a professional, compliant, and timely manner
  • Write and review SOPs and assist in inspection readiness programs
  • Serve as a representative of Prothena to the US regulatory community; serve as a liaison with the FDA to support effective professional and company relationships
  • Educate cross-functional teams on regulatory pathways and requirements to ensure effective product development and registration as applicable to assigned programs
  • Maintain an effective archiving system for assigned programs
  • Ensure that the pharmaceutical products distributed in the US meet FDA requirements and support the local commercial organizations
  • In partnership with other regulatory staff, maintain and expand knowledge of regional regulatory requirements and precedents that may affect the clinical development and commercialization of company products
  • Provide training on specific regulatory topics
  • May support contractor selection and coordination of contracted activities
  • May supervise other regulatory staff

Qualifications

  • PharmD, PhD, Masters or Bachelors degree, preferably in life sciences
  • Minimum of 6 years of Regulatory experience, with at least 3 in a similar US-based leadership role; clinical regulatory experience and experience leading FDA interactions is required
  • Ability to oversee regulatory activities and manage processes from research/discovery, CMC, and clinical and manage process from clinical development through to commercialization; US registration experience preferred
  • Experienced with IND submission and maintenance as well as PSPs (Pediatric Study Plans)
  • Knowledge of US procedures (fast to market procedures would be an advantage)
  • Post marketing/life-cycle management experience (Supplements, Renewals and Labelling) preferred
  • Experience with orphan diseases, monoclonal antibody development, CMC is preferred
  • Familiarity with EU and RoW CTA/MAA regulatory processes preferred
  • Regulatory Project Management experience
  • Excellent written and verbal communication skills
  • Ability to build/forge relationships with key parties (e.g., FDA)

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and core values – courageousness, creativity, selflessness and humor
  • Must possess excellent interpersonal skills
  • Must have the ability to build and maintain positive relationships with management, peers, and direct reports
  • Ability to build/forge relationships with key parties (e.g., Competent Authorities, Vendors)
  • Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail essential.

Travel requirements:

  • Up to 10 % travel required: U.S. and Europe

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