Senior Associate , Reg Affairs International

San Rafael, CA 94901

Posted: 05/16/2019 Employment Type: Direct Hire Industry: Regulatory Affairs & Compliance Job Number: 6183

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 Manager 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 and variations 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, labeling, 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, 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 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.
  • Skilled at gathering supportive information and developing product approval strategies.
  • Proven track record of achieving regulatory goals in ambiguous and sometimes challenging situations.

Desired Skills:

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

 

EDUCATION

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