Regulatory Affairs Manager
Recruiting.com
full-time
Posted on:
Location Type: Remote
Location: Indonesia
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About the role
- Regulatory Affairs activities for lifecycle management of pharmaceutical products
- 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
- Update/local Production Information (Labelling translation)
- Check regulatory compliance of product information/artworks
- Marketing Authorization withdrawal
- Management of local Regulatory Affairs requirements (local regulatory intelligence)
- 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
Requirements
- 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
- Bachelor's or Master’s degree in Pharmacy, Life Sciences, or a related field
Benefits
- Benefit offerings outside the US may vary by country and will be aligned to local market practice.
- The 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 compliancechange applicationslifecycle managementmarketing authorizationlocal regulatory intelligencesubmission strategydeficiency letter management
Soft skills
project managementstakeholder engagementindependent workcross-functional communicationissue management
Certifications
Bachelor's degree in PharmacyMaster’s degree in Life Sciences