Regulatory Operations Specialist
New
J
JobgetherFood, Pharmaceuticals, Supplements
Based in the United StatesFull-TimeMiddle
SalaryCompetitive salary range of $70,000 - $85,000 annually.
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Job Details
- Languages
- Fluent English
- Experience
- Minimum of 5 years
- Required Skills
- Project ManagementQuality AssuranceStakeholder management
Requirements
- Bachelor’s degree or higher in Food Science, Pharmaceutical Science, a related scientific discipline, or equivalent experience.
- Minimum of 5 years of experience in regulatory affairs, quality, R&D, or related functions within the food, supplement, or pharmaceutical industry.
- Experience with regulatory registration processes, submission requirements, and compliance documentation is preferred.
- Knowledge of regulatory dossier preparation and market submission processes is a strong advantage.
- Experience managing projects and collaborating with cross-functional teams.
- Familiarity with regulatory systems, document management platforms, or registration tools is preferred.
- Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
- Excellent attention to detail and ability to perform accurate document reviews.
- Strong communication and stakeholder management skills.
- Fluent English communication skills; additional languages are considered a plus.
Responsibilities
- Follow regulatory submission plans and coordinate timelines with international business teams, market regulatory teams, distributors, and global stakeholders.
- Manage the preparation, compilation, and review of regulatory submission dossiers for new registrations, renewals, and post-submission activities.
- Collaborate with factories, R&D teams, quality teams, and regulatory stakeholders to collect required documentation and ensure submissions meet market requirements.
- Perform final quality reviews of regulatory documents to ensure accuracy, completeness, and compliance before submission.
- Manage regulatory projects through registration management systems, maintaining submission records, requirements spreadsheets, and license databases.
- Support the creation and harmonization of regulatory document templates across markets and product categories.
- Assist stakeholders with training and guidance on regulatory registration systems and processes.
- Coordinate management of change controls, including regulatory assessments, documentation updates, and communication activities.
- Support import and export activities by providing required regulatory documentation.
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