Regulatory Affairs Manager
Recruiting.com
full-time
Posted on:
Location Type: Remote
Location: Vietnam
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About the role
- Regulatory Affairs activities for lifecycle management of pharmaceutical products
- Support change applications including submission strategy
- Dossier compilation including preparation of documents and Table of Contents
- Content review of Chemistry, Manufacturing & Controls documentation
- Alignment with functions on variation procedures and deficiency letters
- Update/local Product Information
- Check regulatory compliance of product information/artworks
- Handle Marketing Authorization withdrawal and transfer
- License renewal and Periodic Safety Update Report contribution
- Manage databases maintenance and local regulatory requirements
- Cross-functional communication regarding regulatory strategy and submission issues
- Review of Promotional Materials
Requirements
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field
- Minimum of 5 years’ experience working in regulatory affairs within the pharmaceutical or healthcare industry or in a consulting setting
- Excellent project management and stakeholder engagement skills
- Ability to work independently and in a fast-paced consulting environment
Benefits
- Benefit offerings outside the US may vary by country and will be aligned to local market practice
- Eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsdossier compilationcontent reviewregulatory complianceMarketing Authorizationlicense renewalPeriodic Safety Update Reportdatabase maintenancepharmaceutical productschange applications
Soft skills
project managementstakeholder engagementindependent workcross-functional communicationfast-paced environment
Certifications
Bachelor’s degreeMaster’s degree