Regulatory Affairs Manager
Recruiting.com
full-time
Posted on:
Location Type: Remote
Location: Thailand
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About the role
- Regulatory Affairs activities for lifecycle management of pharmaceutical products including but not limited to: Support change applications (Administrative, Labelling, Chemistry, Manufacturing & Controls, Safety) including submission strategy
- Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents
- Content review of Chemistry, Manufacturing & Controls/Labelling documentation/Justification documents
- Alignment with functions on variation procedures, deficiency letter, e.g, Chemistry, Manufacturing & Controls, Medical Science, publishing team
- Update/local Product Information (Labelling translation)
- Check regulatory compliance of product information/artworks
- Marketing Authorization withdrawal
- Marketing Authorization Holder transfer
- Licence renewal
- Periodic Safety Update Report contribution
- Invoice check (e.g. Authority invoices)
- Request Translation/additional Module 1 documents, e.g. Quality Practices declaration, Good Manufacturing Practices
- Databases maintenance: archiving, tracking
- Management of local Regulatory Affairs requirements (local regulatory intelligence)
- National Competent Authorities electronic systems for submission as locally required
- Contact with the local Health Authority on behalf of the client
- Cross-functional communication to all relevant departments in relation to regulatory strategy and submission as well as issues related to Lifecycle Management activities
- Support of Country Regulatory Affairs Head in issue management (e.g. Product Quality Controls Standards Quality, Safety issues like stock out situations management, Dear Healthcare Professional Letter preparation coordination and submission in accordance with local regulations and company Standard Operating Procedures, represent Regulatory Affairs in internal meetings and committees)
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsdossier compilationcontent reviewregulatory compliancemarketing authorizationlicence renewalperiodic safety update reportdatabases maintenancegood manufacturing practicesproject management
Soft Skills
stakeholder engagementindependent workcross-functional communicationissue management