Senior Associate, Regulatory International

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. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. 

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing 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. 
Senior Associate
, Reg Affairs International

SUMMARY

We are seeking a highly motivated, energetic professional capable of working effectively in a fast-paced environment to join our Regulatory Affairs International team. The Regulatory Affairs International Senior Associate is responsible for supporting global regulatory activities for new product registration and life-cycle maintenance in Latin America, Asia Pacific, Eastern Europe/Asia Minor and Middle East/Africa.

RESPONSIBILITIES

  • Understand regional laws, regulations, guidance, and global regulatory requirements while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards.
  • In conjunction with regional leads and experts, manage project timeline, planning and preparation and submission of marketing applications, orphan drug applications, variations and license renewals to support LATAM, APAC and EEAM/MEA regions. Must ensure all submissions are prepared in accordance with regional regulations.
  • Participate on interdisciplinary regulatory teams in establishing global regulatory strategy
  • Provide regulatory support to team members located in global offices.
  • Manage the writing or updating of various sections of the MAs including the administrative, nonclinical, and clinical portions of MAs.
  • Act as a main point of contact for specific projects and serve as an international regulatory representative on project sub-teams. The candidate will need a thorough understanding of commercial plans in order to provide insights on the feasibility for market entry.
  • Participate in international health authority meetings, as required.
  • Communicate with regulatory consultants regarding product development plans.
  • Perform regulatory intelligence searches for registration and other regulatory requirements in applicable global regions.
  • Flexible work schedule to maximize global interactions, as required.
  • Up to 10% travel for regional business, health authority meetings, etc. may be expected.

EXPERIENCE

Required Skills:

  • Minimum of 4-5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries with clinical regulatory department, including an in-depth knowledge and understanding of the Regulatory environment. International regulatory experience preferred.
  • Proven ability to manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting clinical part of major regulatory submissions.
  • Ability to successfully manage multiple projects to deadlines.
  • Thorough understanding of relevant drug development and post-marketing regulations and guidelines and have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
  • Proven track record of achieving regulatory goals in ambiguous and sometimes challenging situations.

Desired Skills:

  • Rare disease and clinical experience is preferred
  • International experience is preferred
  • Bilingual/multilingual language skills are a plus

EDUCATION

  • Bachelor's degree in a science/life sciences. 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.