- Perform high-level formatting in both Word and PDF files, including creating bookmarks, hyperlinks, file optimization, optical character recognition, etc.
- Review submissions for compliance with FDA Technical Specifications.
- Submit eCTD submissions through the ESG FDA gateway. Collaborating with the publishing operations lead to publish high-quality submissions and ensure all components meet eCTD format requirements.
- Handle submissions for Pre-approval, Post-Approval, and Promotional Material.
- Develop and maintain an understanding of relevant regulatory requirements for US submissions.
- Support the implementation of necessary Regulatory publishing systems, including assistance with validations, qualifications, and verifications of the systems.
- Provide timely and effective support and troubleshooting of the Electronic Submission System.
- Support the preparation and implementation of Publishing Operations processes and standards.
- Perform administrative tasks related to the submission and transfer files to FTP Server.
- Input information about submissions into internal databases/systems per internal requirements and procedures.
- Other duties may be assigned.
- Adapt to changing environments.
- Ability to prioritize and multitask.
- Organized and detail oriented.
- Sense of urgency to meet all required deadlines.
- Bachelor's degree from a 4-year college or university; over 3 years of pharma experience and/or training; or equivalent combination of education and experience.
- Experience with NDA and/or BLA submissions will be a plus.
- Proficient in Microsoft Office (Word, Excel, PowerPoint, and Outlook).
- Expertise in Adobe Systems (Pro Acrobat DC).
- Familiarity with Practice Database systems (DocuBridge, Veeva Systems, eCTD Manager, Liquent Insight publisher, etc.).
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Regulatory Affairs Sr. Associate - Chicago, United States - Meitheal Pharmaceuticals Inc
Description
ApplyJob Type
Full-time
Description
About Meitheal Pharmaceuticals
Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a leading provider in the development and commercialization of generic injectables, fertility, biologics, and biosimilars. With a commitment to providing affordable and accessible healthcare solutions, Meitheal markets over 50 FDA-approved products across multiple therapeutic areas. Our mission is to work collaboratively towards a common goal, for the greater good. Ranked among the top 100 Crain's Best Places to Work in Chicago, Meitheal embraces the guiding principle of Meitheal-working together towards a common goal.
Position Overview
The Regulatory Affairs Senior Associate - Publishing is responsible for providing effective support to the Publishing Operations function within Regulatory Affairs. This role includes utilizing publishing systems and processes for the preparation of high-quality submission dossiers, ensuring compliance with FDA regulations and internal policies/procedures. Pharmaceutical experience is required.
Essential Responsibilities
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
Computer Skills
AAP/EEO Statement
Meitheal Pharmaceuticals is an Equal Opportunity Employer. We encourage applications from Minorities, Women, Veterans, and individuals with disabilities.
Apply Now
Join our team at Meitheal Pharmaceuticals and contribute to our mission of providing affordable and accessible healthcare solutions. Apply today to be a part of our collaborative and innovative work environment
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