Regulatory Affairs Associate II
2 months ago
The opportunity
The RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of applying them effectively to all work output.
How you’ll spend your day
Develop labeling documents to ensure alignment with the Reference Listing Drug. This includes QC, proofing, editing and formatting of documents, and coordinating the review and approval of final submission documents with US Labeling Team members. Create, revise, and prepare labeling documents needed for full responses to FDA via appropriate filing mode. This includes but is not limited to development of content of labeling, side-by-side comparisons, SPL update and other required submission materials, as necessary. Work within the team to proofread established labeling files for content accuracy either manually or by utilizing the electronic proofreading tool TVT. Work with US Regulatory Labeling Team to ensure assigned projects like RLD updates, Safety labeling changes, Annual reportable changes, Electronic Medication Guide initiatives etc. and any other projects as per requirement 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 with minimum supervision. Assists the Group leader in the assignments and review of labeling documents. Performs all other job-related duties as required by management.
Your experience and qualifications
Qualifications:
M.Sc./M Pharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience.:Experience
Total years of experience required for the role: - 4 plus years US Labeling experience. Relevant years of experience: 4 plus years (Pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on US Gx labeling
Knowledge and Skills
Individual must:
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 minimum supervision. Have knowledge of FDA US regulations and guidance's related to US Gx labeling. Have knowledge of FDA eCTD submission standards and experience in applying these requirements to routine labeling submissions submitted.Specialized or Technical Knowledge
PC, Microsoft Office Suite with a proficiency in Microsoft Word Adobe Acrobat Professional is a must. Familiarity with TVT preferred.-
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