Manager Regulatory Affairs
1 day ago
Combine knowledge of scientific, regulatory and business issues to enable Abbott Nutrition products/business activities to meet required legislatio..
- Combine knowledge of scientific, regulatory and business issues to enable Abbott Nutrition products/business activities to meet required legislation.
- Develop and supervise regulatory professionals.
- Have department level influence and be generally recognized as an expert resource both within Abbott and externally.
- May comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information.
- Monitor emerging regulatory issues and identify solutions.
- Ensure that data are identified, obtained and effectively presented for the registration of products worldwide.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Accountable for compliance with applicable Corporate and Divisional Policies and procedures and evaluation of regulatory risks of these documents.
- Accountable for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs.
- Identify need for new regulatory policies, processes and SOPs and approve them; evaluate regulatory risks of corporate policies.
- Provide strategic guidance for product development and planning throughout the product lifecycle.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and work with appropriate teams to develop solutions.
- Conduct regulatory due diligence for potential and new acquisitions and advise management.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
- Develop global regulatory strategies and update based upon regulatory changes.
- Interpret and apply regulatory requirements.
- Monitor and influence external environment for impact on company products/business activities (e.g., regulation changes, government practices, trade association activities, etc.).
- Ensure regulatory data is maintained in electronic systems.
- This is a contract role for 6 months
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