Icon hamburger
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Default4

Senior Regulatory Affairs Associate

San Rafael, Ca Full-Time
$90,000.00 - $120,000.00 / year
Apply Now

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.

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.

Recommended skills

Latin (Language)
Multitasking
Marketing
Scheduling
Biotechnology
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.