The Opportunity:The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities.
Responsibilities:
- Provide support for the preparation, quality review, and coordination of regulatory submission documents and global CTA submissions across programs.
- Establish and manage the Regulatory Intelligence newsletter, including content development, sustainable distribution processes, vendor management, and continuous process improvements.
- Identify opportunities to improve Regulatory Science processes/workflows and independently lead or assist implementation of approved solutions.
- Support the maintenance of Regulatory Information Management (RIM) systems and electronic document repositories to ensure data accuracy and compliance.
- Work closely with Global Filing Team, Business Excellence group and external vendors.
Required Skills, Experience and Education:- Bachelor's degree in a relevant field.
- Two or more years prior experience in a Regulatory Affairs department at a drug or biologics company.
- Some Familiarity with regulatory requirements for development of drug and biological products, including FDA regulations and guidance, and ICH guidelines.
- Willing to advance knowledge of regulatory practice through classes, certifications, webinars.
- Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system.
Preferred Skills:- Experience in oncology drug development.
- Experience with supporting the preparation and submission of large complex regulatory submissions.
#LI-JC1 #LI-Hybrid
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Base Pay Salary Range
$120,000-$150,000 USD
