Performs day-to-day activities related to organization and submission of regulatory documents directly to Federal Drug Administration (FDA).
Include the following. Other duties may be assigned.
- Compile, prepare, and submit routine regulatory submissions and provide support for various regulatory submissions including NDAs, ANDAs, Amendments and Supplements to FDA and other regulatory agencies.
- Interact with Research & Development, Quality Assurance/Quality Control (QA/QC), and Production for gathering data and documentation for submissions.
- Create CTD format narrative for ANDA Application and submit the ANDA in CTD/eCTD format to the Agency.
- Review and audit data submitted by technical departments (R&D, QA/QC) and outside firms.
- Assist in developing draft labeling for proposed and existing drug products.
- Review product labeling for compliance with regulatory guidelines.
- Generate Standard Operating Procedures (SOPâ€™s) as needed for the Regulatory Affairs group.
- Remain cognizant of important developments in FDA and other regulatory agencies that may impact product line.
- Organize and maintain Regulatory Affairs department files.
- Collaborate with 3rd party companies for US regulatory submissions.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed 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 EXPERIENCE:
- Excellent telephone and written communication skills with proven prior experience.
- Working knowledge of US regulatory submission.
- Proficient with computer programs desirable; or an aptitude to learn computer programs as needed.
- Resourceful and well organized.
- Have general math skills; adding, subtracting, multiplication, division and percentage calculation.
Company Overview Who we are?
- Minimum B.S./B.A. degree, Chemistry or Biological sciences desired, but not absolutely required.
- Minimum of 2 years previous work experience pharmaceutical industry preferably in areas of research and development, drug regulatory affairs, documentation, compliance, etc.
Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patientsâ€™ lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com . Why choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!What do we offer?
- Competitive pay
- Growth and development opportunities
- Tuition Reimbursement
- 3 weeks PTO + Personal Days
- 9 company holidays
- 401K match
- Medical, Dental and Vision Benefit Options
- 100% Paid Maternity Leave
- Fast paced, family-oriented work environment
- Wellness Program
- Inclusive and diverse culture
- Adoption Assistance
- Flexible Spending Accounts
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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