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Regulatory Affairs Associate II at Amneal Pharmceuticals LLC in Piscataway, New Jersey

Posted in Science 30+ days ago.

Type: Full-Time





Job Description:

Description:


  • The Regulatory Affairs Associate II, with minimal guidance, prepares, reviews and submits high quality, regulatory submissions such as ANDAs to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.

Essential Functions:


  • The Regulatory Affairs Associate II, with minimal guidance, prepares, reviews and submits high quality, regulatory submissions such as ANDAs to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.


  • With minimal guidance, ensures compilation and completion of ANDAs with high-quality, following regulatory guidelines and internal processes within time lines.


  • Coordinates with external vendors for project support activities. This may include but is not limited to: RS statements, TSE/BSE statements, melamine free certificates, cGMP certificates, debarment certificates, US agent letters, DMF LoAs, technical data sheets and technical drawings, quantitative compositions of colors, flavors etc. Follows up with purchase team for DMFs and compliance to DMF review comments.


  • Organizes and maintains submission components associated with a regulatory submission electronically. This may include scanning, converting to PDF, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress etc. under some senior associate or managerial guidance.


  • Screens the ANDAs against ANDA checklist to avoid screening queries. Screens the ANDAs against Refuse-to-Receive (RTR) Standards Guidance to prevent deficiencies that could result in RTR's from the FDA.


  • Tracks the committed timeliness and follows up with the internal departments proactively for required documents.


  • Prepares and updates the road map for each assigned product with committed timeliness by each department.


  • Reviews DMFs and follows up with purchase team as needed to ensure comp(liance.

Additional Responsibilities:


  • Gains knowledge in the use of e-CTD structures for submissions.


  • Works with colleagues in resolving regulatory issues and/or problems.


  • Archives and maintains all submissions in a systematic way.


  • Performs administrative functions as directed by management to support projects and to ensure the smooth operation of the department.


  • Maintains current knowledge of regulations and other issues that affect products and industry.


  • Maintains the regulatory databases up to date and as per the set criteria.

Education:


  • Bachelors Degree (BA/BS) Science or Technical - Required


  • Master Degree (MS/MA) - Preferred

Experience:


  • 3 years or more in 3 years or more Regulatory submission related work

Skills:


  • Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. - Intermediate


  • Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. - Advanced


  • Excellent written and verbal communication skills and interpersonal skills. - Intermediate


  • Ability to communicate effectively and collaboratively as part of a team in a respectful manner. - Intermediate


  • Ability to interface with professionals domestically and abroad. - Intermediate


  • Ability to work independently, self-starter. - Intermediate


  • Good problem-solving skills and analytical ability. - Intermediate


  • Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Outlook and Adobe Acrobat is a must. - Advanced

Specialized Knowledge:


  • Proofreading abilities.


  • Working knowledge and experience with 21 CFR, US FDA guidance, ICH guidelines