American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- With supervision, author and compile regulatory submissions in accordance with applicable ICH, CFR, and FDA guidance within specified timelines. This includes but is not limited to ANDA, PAS, CBE and Annual report submissions.
- Compile high-quality submissions in eCTD format in compliance with applicable regulations and FDA guidance employing use of submission publishing tools and software
- Participate in 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 process improvements, review and/or author assigned SOPs, protocols, technical documents and stability reports to ensure suitability for regulatory filing under direction of senior RA personnel
- Perform any other tasks/duties as assigned by management.
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 2 Years in the pharmaceutical industry or equivalent preferred
- Experience with regulatory submissions preferred
- Experience with generic drugs or sterile products 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.
- Knowledge of FDA regulations and cGMP requirements; Intermediate proficiency.
- Must be able to work well in a team environment with strong attention to detail; Advanced proficiency.
- 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/Careers accessible 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 Roz Russo, Talent Acquisition Senior Manager at 631-205-2068 or email at firstname.lastname@example.org