The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Lead the authoring and eCTD compilation of Original, Lifecycle and Compliance related FDA regulatory submissions under direction of senior RA personnel
Author and peer review regulatory submissions in accordance with applicable ICH, CFR, and FDA guidance within specified timelines. This would include but not be limited to NDA, ANDA, PAS, CBE, Annual report and Complete Response/Information Request submissions.
Compile high-quality submissions in eCTD format and execute peer review for compliance with applicable regulations and FDA guidance employing use of submission publishing tools and software
Lead meetings and interact with members of the project team and sub-teams to drive submission timelines and determine risks to filing, escalating to management when appropriate
Review and approve proposed changes to established regulatory conditions to ensure compliance with FDA guidelines and to maintain adequate control and flexibility for the lifecycle management of the commercial product portfolio under direction of senior Regulatory Affairs personnel
Identify and implement process improvements, author and/or review assigned SOPs, protocols, technical documents and stability reports to ensure suitability for regulatory filing under direction of senior RA personnel
Education Requirements and 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.
Bachelor's Degree in a life science or other related field required
Minimum 3 Years in the pharmaceutical industry required
Minimum 1 Year experience with regulatory submissions required
Experience with sterile generics and NDAs preferred
Problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision; Advanced proficiency.
Microsoft Office systems; Intermediate proficiency.
Must be able to work well in a team environment with strong attention to detail; Advanced proficiency. Strong organizational, interpersonal and communication skills (oral and written).
Organizational, interpersonal and communication skills (oral and written); Advanced proficiency.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
American Regent Inc. endeavors to make https://americanregent.com/Careersaccessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact John Rossini, Talent Acquisition Director at 631-690-7201 or email at HRTalentAcquisition@americanregent.com
American Regent is a top-10 injectable manufacturer with sales of over $1 Billion. Our growing business is comprised of generic and branded injectables, as well as leading branded IV iron therapies. We hold the leading position for the majority of the products in our portfolio.
For over 50 years, we've set a higher standard for responsiveness and reliability as a US-based manufacturing company with a short supply chain. Every day we are applying our innovative thinking to respond to customer needs by developing and delivering complex, hard-to-manufacture injectables and drug shortage products.