Role : Regulatory Specialist II

Location : Alameda, CA - 94502

Duration : 12 Months

Shift Timings : 8 am to 5 pm

Note :

• List 3-5 hard requirements for the role :
• Responsible for regulatory activities, including product registrations, impact assessment, etc.
• Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc.

for product registration and change planning.

• Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
• Plan and execute the given tasks proactively in a timely manner.
• Report the status to a manager weekly.
• Keep the training records up to date to do the tasks.
• List any preferred requirements that would stand out on a resume :
• understand technical sections (risk management, product change control, biological evaluation)

Years of experience required : 5

• Required education level / certifications : BS, MS
• Daily tasks / duties and department interactions :
• prep submissions, regulatory strategy, review change control, other assigned tasks.
• Interacting with QA, Labeling, Engineer, PMO. Etc.
• Description of work environment / department :
• Assigned Desk, quiet area but dynamic work, Occasional night calls (after 5PM) with Affiliates.
1 hour ago