Regulatory Compliance Associate
Location: South San Francisco, CA 94080
Pay Rate: DOE
Start Date: ASAP
3 Year Contract Role
Department: Tech Reg SM Market
General Overview: Our client, a leading Combination Development company is seeking an entry level Regulatory Compliance Associate in Pharma Technical Regulatory to support 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 our product portfolio.
Duties: The candidate will support the regulatory compliance team with maintenance, archival and retrieval of regulatory submission information.
- Ensure that the quality, content, and format of regulatory submissions comply with applicable regulations and guidelines
- Provide support with the publishing of regulatory submissions and handle communications with stakeholders, as needed.
- Ability to work effectively and collaboratively with different project teams across sites.
- Use his/her knowledge of internal systems to handle urgent requests including requests for specific information in regulatory dossiers.
- Responsible for running required reports and the use of relevant tools to efficiently and accurately publish quarterly regulatory reports.
- Maintain a high level of professionalism, efficiency, and commitment.
- Demonstrate attention-to-detail, effective problem solving, and the ability to prioritize multiple tasks.
Skills and 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.
- 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
Please submit your resume in Word or PDF version to be considered.