Regulatory Affairs Associate I, Labeling

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

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 guidance 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.

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

• Pharma Graduate/Postgraduate with a scientific or regulatory background, or an equivalent combination of education and experience.
• Bachelor’s in pharmacy/Master’s in science & Life sciences- 2-3 Years in the Pharmaceutical Industry.
• Master’s in pharmacy-1-2 Years in the Pharmaceutical Industry.
• Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry.
• 1 to 3 years of pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on US Gx labeling.
• Knowledge of SPL development and drug listing requirements.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.