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Regulatory Affairs Associate III (CMC)
The Regulatory Affairs Associate III, independently prepares, reviews without appreciable direction 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.
- Compile and complete high quality ANDAs and Amendments ensuring final submission meet requirements of ANDA checklist recommended by USFSDA to avoid any acceptance to file issues. Ensure all submissions and projects are completed with the expected timeline. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. Provides guidance and direction to junior employees
- Coordinates with external vendors for project support activities. This may include but 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., Follow up with purchase team for DMFs and compliance to DMF review comments.
- Organize and maintain 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. independently.
- Reviews ANDAs against Refuse-to-Receive (RTR) Standards Guidance to prevent deficiencies that could result in RTR’s from the FDA – review includes a critical detailed assessment that technical documentation and information is available, accurate and complete for submission. Provides guidance and direction to junior employees for screening of ANDA’s against the checklist.
- Represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues. Prepare and update the road map for each assigned product with committed timeliness by each department.
- Evaluate change controls and formulates strategies for correct filing categories, with guidance from manager. Proactively raises major project issues if any to manager for resolution and agreement.
- Review the API DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time.
- Works with colleagues in resolving regulatory issues and/or problems
- Should archive and maintain 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.
- Bachelors Degree (BA/BS) in Science or Technical – Required
- Master Degree (MS/MA) in Science or Technical – Preferred
- 4 years or more Regulatory submission related work – Required
Skills and Abilities
- Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities. – Advanced
- Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. – Advanced
- 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. – Advanced
- Ability to communicate effectively and collaboratively as part of a team in a respectful manner. – Intermediate
- Ability to work independently, self-starter. – Advanced
- Good problem-solving skills and analytical ability. – Advanced
- Ability to work with professionals domestically and abroad – Advanced
- Strong skills in MS Word, MS Excel, MS PowerPoint, MS Outlook, Adobe Acrobat Professional, ISIWriter, ISIToolBox and eCTDXpress software.
- Proofreading abilities.
- Working knowledge and experience with applicable regulations 21 CFR, US FDA guidelines, ICH guidelines, US, EU and AU regulatory agencies.
- 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.
Job posted: 2022-11-07