
Senior Regulatory Compliance Professional
2 days ago
The ideal candidate will possess a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.
Key Responsibilities:
- Preparing, reviewing, and submitting regulatory filings to global health authorities
- Ensuring compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices
- Interacting with regulatory authorities during product submissions, inspections, and audits
- Developing and maintaining regulatory strategies to support new product development and lifecycle management
- Reviewing labeling, promotional materials, and product packaging for compliance with applicable regulations
Additional Responsibilities:
- Maintaining up-to-date knowledge of regulatory changes, guidelines, and industry best practices
- Supporting quality systems in alignment with ISO 13485, ICH, and FDA QSR standards
- Collaborating with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development
Requirements:
- Strong analytical and problem-solving skills
- Excellent communication and project management skills
- Ability to work in a fast-paced environment and prioritize multiple tasks
Benefits:
- Competitive salary and benefits package
- Opportunities for career growth and professional development
- A dynamic and supportive work environment
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