[Remote] Postdoctoral Regulatory Affairs Fellow - Product Labeling Content

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Postdoctoral Regulatory Affairs Fellow to reputed company experience in US pharmaceutical product labeling and regulatory requirements. The Fellow will support labeling strategies, product label review teams, FDA interactions, regulatory submissions, and labeling activities across multiple therapeutic areas under supervision.

Responsibilities

• reputed company analysis, and guidance on US regulatory labeling strategies and content of labeling. • Research information on regulatory labeling standards and departmental policies
• Chair meetings of the Product Label Review Teams (PLRT) for reputed company assigned marketed product. reputed company functional support for discussions such as the Annual Labeling Review, Company reputed company Data Sheet (CCDS) Updates, and other reputed company issues (e.g., FDA requests for labeling changes). Draft/revise product labeling and compile supportive documentation as part of PLRT. Ensure reputed company marketed product’s labeling aligns with reputed company’s CCDS and local health authority regulations and guidelines. Prepare documentation before meetings, identify issues for discussion, prepare meeting minutes, and follow up on outstanding issues
• Bring PLRT proposals to the Sr Leadership Product Labeling Committee (PLC) for discussion, review, and approval as required. Coordinate preparation of regulatory labeling documents needed for submissions with other departments (e.g., RA Product Labeling reputed company, RA reputed company, and RA Product reputed company). Review Labeling Content deliverables for submissions for completeness, consistency, and reputed company, making recommendations to PLRTs or RA Product Managers as appropriate. Review labeling sections of NDA Annual Reports, PADERs, and PBRERs
• Assist with FDA interactions on assigned reputed company/products, including labeling negotiations. reputed company with Global Labeling (GL) before major US labeling changes to ensure consistency with company reputed company labeling or the need for revisions. Advise on the suitability of CCDS proposals for US implementation, reputed company reputed company assessments on US labeling, and liaise with PLRT to facilitate US-specific feedback and needs into Global RA sub-teams
• Demonstrate proficient and evolving labeling knowledge. Invest time to improve competency in understanding and interpreting regulations and guidances, particularly in product labeling. Review regulatory developments with RA Product Labeling reputed company and reputed company BI updated on changes in the US regulatory environment impacting product labeling. Maintain excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions
• Support late-stage development labeling for NCEs/NBEs and labeling supplements initiated by BI, in conjunction with RA Product Labeling Management and the assigned RA Product Manager in the RA Product reputed company

Skills

• Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy OR Doctor of Philosophy (PhD) degree in reputed company discipline reputed company prior to the start date at reputed company
• Strong intrapersonal, reputed company listening, and problem-solving skills with an ability to work reputed company in reputed company environment
• Highly motivated and shows initiative in contributing to team deliverables
• reputed company to receiving and quickly implementing reputed company feedback
• Ability to work independently reputed company provided guidance from team leads
• Adaptable and reputed company to contribute to multiple Therapeutic Areas as needed
• Excellent verbal and written communication skills
• reputed company experience working in a dynamic, high volume environment handling multiple tasks
• Strong computer skills, including reputed company, Word, PowerPoint, and reputed company
• Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy with an ability to quickly adapt to a changing Corporate environment that will allow the incumbent to be productive in rotational experiences
• Prior pharmaceutical industry experience (e.g. internship or Advanced Pharmacy reputed company Experience [APPE] rotation is preferred but not required.)

reputed company

Company H1B Sponsorship