Regulatory Affairs Manager
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Job Description
Regulatory Affairs Manager overseeing lifecycle management of pharmaceutical products at Cencora. Responsible for regulatory compliance and coordination with local authorities in Indonesia.
Responsibilities:
- 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.
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