-RA (US Market)
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Job Location:
Monthly Salary:
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
About the role :
Work closely with Regulatory Affairs Associates to ensure the compliance and completion of assigned
activities and provide regulatory strategic input and compliance with FDA regulations guidance and
applicable industry guidelines to internal and external stakeholders and ensure the implementation
Roles and Responsibilities:
Prepares the submissions (ANDAs amendments supplements including labeling annual reports) to
support commercial business and to be-in compliance to FDA regulations.
Review CMC submission documents from regulatory perspective to meet scientific and technical
requirements for acceptability and approvability by FDA. Escalate the review findings for a timely
resolution.
Leads labeling development for product launches and ensures that all labeling meets company and
US regulating health authority specifications.
Initiate/Review change control process and coordinate with other departments to ensure timely
implementation.
Prepare review and submit eCTD submissions.
Collaborates with Regulatory Affairs on submission and implementation strategy for labeling. Create
and revise labeling. Proofread and verify all labeling to ensure accuracy and conformity with US FDA
regulations. Prepare final printed labeling for FDA submissions (e.g. PDF SPL PLR format). Perform
Drug listing.
Qualification:
Excellent written and verbal communication skills. BS in Science/Pharmacy or related degree.
Minimum 5 years of experience in Pharmaceutical Industry (CMC and Labeling).
Key Skills
- Change Management
- Advertisement
- Market Research
- IT System Administration
- Financial Planning
