Associate Director/Director, International Regulatory Product Lead

Location:  San Rafael, California Category: Regulatory

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. The Global Regulatory Affairs group plays an integral role in the development and commercialization of first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives!

Summary

We are seeking a highly motivated regulatory professional capable of working effectively in a fast-paced environment to join our International Regulatory Affairs team. This position will be responsible for leading and executing the global regulatory strategy for expansion of our development product(s) into international markets.

Responsibilities

  • Develop and communicate international regulatory strategy (including clinical/nonclinical, CMC and global labeling) for development product(s) that are in alignment with overall global product strategy, market timing plans and corporate goals
  • Ensure close alignment and coordination with Regional and Country leads
  • Lead the development of global dossier strategy to support international marketing applications for assigned product
  • Provide strategic regulatory insight on clinical/nonclinical aspects of program for regional markets and ensure implementation of regulatory concepts within the global regulatory team and cross-functional project teams
  • Lead preparation of regulatory documentation especially clinical/nonclinical content (e.g., briefing dossiers, global regulatory dossiers, responses to health authority queries, etc.) for international markets in partnership with Regulatory regional leads and GRL
  • Participate/facilitate preparation for regional health authority meetings
  • Participate/facilitate relevant functional area and project team meetings
  • Expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics

Experience/Skills

  • At least 10-15 years of industry experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry with a clinical and nonclinical emphasis
  • Prior experience as a Global Regulatory Lead
  • Strong collaboration and interpersonal skills and ability to develop and maintaining strong connections with regional and country leads as well as other key stakeholders
  • Skilled at gathering regulatory information and developing product approval strategies
  • Proven track record of managing critical projects as a part of an interdisciplinary team
  • Prior experience managing regulatory submissions to deadlines
  • Thorough understanding of relevant drug development regulations and guidelines
  • Outstanding interpersonal and communication (written and verbal) skills
  • Effective task planning and coordination abilities
  • Proficiency with computer and standard software programs (Microsoft Office, PowerPoint and Excel)
  • Experience managing a small team or at a minimum management in a matrix setting

Preferred

  • Rare disease experience is desirable
  • Experience working with international teams

Education

• BA/BS degree in life sciences 
• Advanced degree a plus