Wastewater Project Engineer
10 hours ago
Regulatory Affairs Specialist
Ensures company products comply with regulatory requirements and standards for safety and efficacy.
Key Responsibilities:
- Prepares, reviews, and submits regulatory documents to FDA and other global health authorities.
- Monitors and interprets regulatory developments, communicating potential impact to the team.
- Provides regulatory guidance throughout the product lifecycle, from development through post-market.
- Manages and maintains regulatory timelines to ensure timely submissions and approvals.
- Coordinates with cross-functional teams to ensure compliance with regulatory requirements.
Preferred Skills:
- Advanced degree in life sciences or a related field.
- Experience with electronic submission platforms (eCTD).
- Knowledge of regulatory pathways for new drug applications in the EU, Japan, and other international markets.
Benefits:
- Medical, dental, vision, life insurance, short-term disability, and additional voluntary benefits.
- 401K plan and commuter benefits.
Equal Opportunity Employer/Veterans/Disabled
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