Regulatory Affairs Associate

Bimeda•Houston, TX

About The Position

This role is responsible for Regulatory Affairs aspects of product life cycle management (PLCM) related to post approval submissions and drug product registrations. The Regulatory Affairs Associate builds and maintains strong relationships with colleagues in Quality and Commercial ensuring optimal compliance from cGMP and Regulatory standpoint.

Requirements

Minimum of two (2) years of experience working in a professional office or laboratory environment with responsibility for managing documents, records, and multiple concurrent priorities.
Proficiency in Microsoft 365 applications (Word, Excel, PowerPoint, Teams, and Outlook) and the ability to learn and effectively utilize digital regulatory, document management, and AI-enabled productivity tools.
Experience using Adobe Acrobat Pro, Foxit PDF Editor, or similar document management software.
Strong written and verbal communication skills.
Excellent organizational skills with a high degree of accuracy and attention to detail.
Demonstrated ability to work independently, prioritize tasks, and manage multiple responsibilities effectively.
Self-motivated with a collaborative, team-oriented approach.
Eagerness to learn and develop new skills.
Ability and willingness to travel occasionally (approximately 2%).

Nice To Haves

Minimum of two (2) years of experience in regulatory affairs, the pharmaceutical industry, or a similarly regulated environment.
Associate's, Bachelor's, or equivalent post-secondary degree in a related field.
Experience with FDA electronic submission systems, including eSubmitter and FDA ESG NextGen.
Experience with SharePoint, electronic document management systems (EDMS), information management platforms, and project management software.
Experience or demonstrated skills in project coordination, problem solving, regulatory submissions and or exposure to manufacturing environments.
Understanding use of AI tools such as Microsoft Copilot, ChatGPT or other similar platforms.
Experience supporting document preparation, submission activities, or regulatory records management within a regulated industry.
Knowledge of continuous improvement principles, regulatory monitoring activities, and regulatory risk identification.
Able to build and maintain lasting relationships with cross functional team members.

Responsibilities

Manage regulatory maintenance activities for approved NADA and ANADA products.
Maintain approved NADA and ANADA applications throughout the product lifecycle.
Compile and submit: Annual reports, CMC submissions, Labeling supplements, Correspondence with regulatory agencies.
Maintain regulatory records, submission archives, commitments, and approval histories.
Ensure compliance with applicable regulations, guidance documents and approved filings.
Maintain awareness of evolving FDA and industry requirements through ongoing review of regulations, guidance documents, and industry publications.
Cross-functional communication and data gathering on GMP documentation required for post-approval submissions for US marketed products.
Coordination of appropriate communications and maintenance of state registrations for drug product distribution.
Proficiency in electronic submissions to FDA-CVM.
Perform regulatory reviews and assessment of cGMP documentation. Determine appropriate reporting categories per FDA regulations.