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Regulatory Compliance Associate
Ref No.: 19-04200
Location: South San Francisco, California
This is an excellent opportunity to start a career with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients' lives!  

Duties:
  • As a Regulatory Compliance Associate in Pharma Technical Regulatory, the candidate will have responsibility for providing support to FDA required submissions such as PDUFA,
  • Establishment Registrations, Lot Distribution reports, creation of Certificates of Analysis (CoAs) and other regulatory compliance activities for marketed products across the product portfolio.
  • The candidate will support the regulatory compliance team with maintenance, archival and retrieval of regulatory submission information.
Job responsibilities will focus primarily on marketed products: 
  • The candidate will ensure that the quality, content, and format of regulatory submissions comply with applicable regulations and guidelines.
  • The candidate will provide support with the publishing of regulatory submissions and handle communications with stakeholders, as needed.
  • Candidate must have the ability to work effectively and collaboratively with different project teams across sites.
  • Additionally, the candidate will use his/her knowledge of internal systems to handle urgent requests including requests for specific information in regulatory dossiers.
  • The candidate will also be responsible for running required reports and the use of relevant tools to efficiently and accurately publish quarterly regulatory reports.
  • The Regulatory Associate must maintain a high level of professionalism, efficiency, and commitment. He/She will demonstrate attention-to-detail, effective problem solving, and the ability to prioritize multiple tasks.
  • He/She must be able to communicate effectively in both a written and verbal format.
  • Ability to work both independently and/or collaboratively in a team structure is required.

Skills:
  • Fluency in Microsoft office and GSuite
  • Excellent written and verbal communication skills
  • Ability to work in a fast paced environment
  • Manage multiple projects independently
  • Work in teams in a matrix environment
  • Complete assigned tasks and projects with direct management oversight.
  • Communicate with regulatory, cross-functional personnel, partners and HA authorities in support of project goals under general supervision
  • Able to communicate drivers for project goals internally
  • Website design or coding a PLUS
Education:
A Bachelor’s degree in sciences or higher with a minimum 0-2 years of industry experience in regulatory, manufacturing, or quality related field in the pharmaceutical/biotechnology Industry. Please note this is a not a high level position – no PhD, MD, PharmD will be considered. Ideal candidate would have 0-2 years of experience in industry, internships included