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Work Location: Parsippany, NJ
With minimal guidance, the Associate III will lead and manage applications through the regulatory approval process, including preparation of original ANDAs, NDAs, amendments and related correspondence to the FDA in order to obtain timely approvals. The Associate III may represent the regulatory affairs department through interactive communication with various internal and external stake holders. He/she will also be responsible for evaluating change controls to provide for accurate regulatory filing assessments in accordance to guidance documents. In addition, he/she will accurately populate and maintain the databases and trackers in real time (change control tracker/Global Trackwise (GTW), Workload Tracker and Global Insight).
Very limited travel. Less than 5% domestic & international travel
Essential Duties & Responsibilities:
Percentage of time
1. Independently reviews and prepares regulatory submissions for drug products under development and review by FDA. Interface with R&D on a regular basis to ensure project-specific regulatory strategy is met. From "regulatory point for view” continually assess the product development process and reports and provide feedback to R&D on the ANDA projects assigned.
2. Initiates regulatory strategy on CMC issues throughout the drug development process.
Serve as a regulatory knowledge base by continually working with R&D on ANDA projects and documenting the regulatory strategy on several milestones, such as, QTPP/CQA, composition, product and process design, various specification settings, manufacturing, stability design and stability data analysis.
3. Coordinates responses to the FDA with appropriate personnel and departments to resolve outstanding regulatory filing issues.
Keep current with the FDA/ICH regulations pertaining to GDUFA, CMC and regulatory filing aspects by independent learning, attending conferences and symposiums.
4. Approves IIG ingredients and assures that they are in accordance with the FDA database. Assesses and approves change controls. 10%
5. Manages the preparation for FDA meetings and provides strategic guidance on the organization of these meetings 5%
6. Provides regulatory training to the department on an as-needed basis. Other projects and duties as required/assigned. 5%
Education Required: Bachelor of Science in a scientific discipline.
Education Preferred: Master's degree
Experience Required: 4 years in Pharmaceutical Industry and a minimum of 4 years in Regulatory Affairs.
(Previous Injectable/sterile product experience required for steriles position).
Experience Preferred: 3-5 years of experience working within Regulatory Affairs (CMC) with a strong background in the generic pharmaceutical industry.
Specialized or Technical Knowledge Licenses, Certifications needed: RAC certification beneficial but not required; working knowledge of CMC as needed for ANDA submissions. Prior pharmaceutical experience involving chemistry and/or manufacturing.
• Possesses strong critical and logical thinking.
• Demonstrates an understanding of ICH and FDA guidelines
• Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
• Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts
• Demonstrates excellent verbal and written communication skills.
• Shares concepts, ideas, information, and suggestions with management, peers and others.
• Demonstrates the ability to evaluate regulatory documents and determine appropriate action.
• Demonstrates the ability to provide regulatory assessment to other departments with little or no supervision.
• Demonstrates the ability to coordinate submissions independently in a time intensive situation.
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