job title: Regulatory affairs associate(teva)

How you’ll spend your day

• 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.

Your experience and qualifications

• 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.