Regulatory Affairs Manager

Highly Competitive
  1. Permanent
  2. Project Manager
  3. United States
San Mateo, California
Posting date: 28 May 2019

A vacancy has arisen for a Regulatory Affairs Manager with an internationally renowned pharmaceutical company, based in their California office. This organization is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organization and support their innovative impact on the healthcare field.

Job Responsibilities:

  • Preparing and submitting moderately complex regulatory documents which require extensive interactions with departments outside of Regulatory Affairs for maintenance of products for assigned territories in line with ICH requirements, regional requirements, and scientific and company policies and procedures.
  • Contributing to the development and regulatory review of documents required for maintenance of products in assigned territories in line with ICH requirements, regional requirements, and scientific and company policies and procedures.
  • Ensuring that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements.
  • Participating in group, local, and global product submission team meetings, presenting project status updates and strategy approaches to moderately complex programs/projects.
  • Providing regulatory expertise to submission teams on specified projects and topics.
  • Initiating or contributing to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.

Skills and Requirements:

  • Degree in a scientific field is preferred.
  • 5+ years of experience in Regulatory Affairs or other relevant industry experience.
  • Knowledge and understanding of US regulations and guidelines.
  • Previous experience in the preparation and submission of clinical/non-clinical regulatory documents in support of US IND and NDA.
  • Experience with marketed products is a plus.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Sherron Howard at + 267 435 8600 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.