Associate Regulatory Affairs Manager - Abbott Nutrition Division
Core
Coordinate and document regulatory processes for Food/Nutritional products and Medical Devices, ensuring compliance with FDA and National Dairy Authority regulations.
Role type
Associate Regulatory Affairs Manager
Builds
Regulatory dossiers, submissions, and product licenses for nutritional and medical device products
Domain
Healthcare / Nutrition / Medical Devices
Required skills
Regulatory affairs experience, FDA regulations knowledge, local product registration knowledge, dossier preparation, clinical documentation review, label and packaging development, compliance self-audits, project management, analytical skills
Preferred skills
FDA Center for Food regulations experience
Technologies
Microsoft Word, Excel, PowerPoint, Adobe Acrobat Professional
Responsibilities
Prepare quality regulatory dossiers for Food/Nutritional products, Drugs, and Medical Devices; Request and obtain regulatory documents required for local submissions; Review clinical documentation to support product label claims; Implement submissions and maintain appropriate regulatory archives; Gain regulatory approvals from FDA and other relevant regulatory agencies; Provide quality responses to regulatory authorities within required timelines; Perform regulatory responsibilities related to label and packaging development; Maintain compliance of marketed products with local and corporate regulatory requirements; Conduct compliance self-audits to identify potential compliance issues; Review promotional materials in accordance with established policies; Keep abreast of regulatory updates, changes, and trends that may impact the business environment and communicate implications to relevant stakeholders; Maintain and strengthen communication with FDA, National Dairy Authority, and industry associations
Seniority
Mid-level, specialist/supervisory