- Internships /
- Regulatory Affairs Specialist CMC
Regulatory Affairs Specialist CMCBookmark This
Posted: November 15 2016
Always be on the alert for potentially fraudulent job postings online - never send money to a potential employer.
Performs day-to-day activities related to organization and submission of regulatory documents directly to Federal Drug Administration (FDA) with focus on chemistry, manufacturing, and controls (CMC) sections.
Include the following. Other duties may be assigned.
- Compile, prepare, and submit routine regulatory submissions (CMC-Module 3) and provide support for various regulatory submissions including NDAs, ANDAs, Amendments and Supplements to FDA and other regulatory agencies.
- Review and evaluate scientific data, analytical methods and reports required for regulatory submissions for consistency to relevant FDA/ICH CMC guidelines.
- Prepare or critically review Quality Overall Summaries (QOS’s) of regulatory submissions.
- Prepare or critically review responses for FDA Complete Response (CR) letters and Information Requests.
- Evaluate change controls and provide accurate regulatory filing assessments in accordance to guidance documents.
- 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.
- Review product labeling for compliance with regulatory guidelines.
- Generate Standard Operating Procedures (SOP’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.
- A strong scientific background with extensive experience in data review along with knowledge and understanding of pharmaceutical development (Quality by Design), method validations, and process controls.
- Capable of interacting with technical groups and understanding complex issues pertaining to CMC.
- Experience in the preparation of CMC sections of eCTD filings
- Excellent telephone and written communication skills with proven prior experience.
- 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.
EDUCATION AND EXPERIENCE
- B.S./B.A. degree, Chemistry or Biological sciences.
- Five (5) years previous work experience in the pharmaceutical industry preferably in area of research and development, drug regulatory affairs, product development, or analytical chemistry.
Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT
Requires prolonged sitting. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriate reports.
Mental Requirements include:
- Ability to hear accurately the spoken word with moderate office noise or plant noise
- Ability to apply deductive reasoning and understand complicated issues
- Ability to receive instructions and follow work rules and company policies
- Ability to follow safety and security practices
- Ability to meet deadlines and effectively deal with office stress
- Ability to accurately communicate ideas, facts and technical information
- Maintain confidentiality of certain information
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
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.