Regulatory Affairs Associate I

The RA Associate I, under direct supervision, is responsible for the preparation and revision of high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2, if required, while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of US FDA labeling regulations and guidances to the level of applying them effectively to all work output in addition to developing compliant Structured Product Labeling (SPLs) files with complete drug listing information.

• Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents.
• Establish SPL for assigned projects. Ensure product data elements align with the required drug listing regulations.
• Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes, but is not limited to, the development of side-by-side comparisons, SPL, and other required submission materials, as necessary.
• Perform quality reviews of labeling and submission documents by proofreading established labeling files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT.
• Work with Regulatory Operations as well as in Teva s publishing software to ensure assigned projects are submitted on time following the eCTD requirements related to labeling.
• Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling.
• Work in a team environment.
• Perform all other job-related duties as required by management and dictated by process changes.

• Bachelor s in pharmacy/Master s in science & Life sciences- 2-3 Years in the Pharmaceutical Industry.
• Master s in pharmacy-1-3 Years in the Pharmaceutical Industry.
• Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry with a focus on US Gx labeling.
• Knowledge of SPL development and drug listing requirements.
• Be able to multi-task in a fast-paced work environment.
• Have exemplary oral and written communication skills.
• Be organized with a keen attention to detail.
• Have the ability to work independently as well as in a team environment with minimal supervision.
• Have knowledge of US FDA regulations and guidances related to US Gx labeling.
• Have knowledge of US FDA eCTD submission standards and experience in applying these requirements to routine labeling submissions.
• Proficiency in PC and Microsoft Office Suite, including Microsoft Word and Microsoft Excel.
• Adobe Acrobat Professional is a must.
• Familiarity with TVT is preferred.