Regulatory Affairs Manager
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Job Description
Regulatory Affairs Manager overseeing lifecycle management of pharmaceutical products for Cencora. Ensuring regulatory compliance and effective collaboration across departments in the pharmaceutical industry.
Responsibilities:
- 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
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