Regulatory Affairs Specialist

Regulatory Affairs Specialist

Jost Chemical is seeking ambitious, hard-working talent for the Jost Quality Assurance Team!

Are you looking for a career at a fast-paced environment, where your hard work and dedication will pay off? Are you a team player, who sets goals to get the job done and would like to use your skills to grow with a great company?

Then, this position is right for you!

Regulatory Affairs Specialist

Position: Full time

Our offer:

• Medical/Dental/Vision Plan Insurance, Short and Long-Term Disability and Life Insurance after 60 days.
• 3% Safe Harbor contribution to your 401k.
• Paid Time Off (PTO) Employees eligible after 90 days of continuous employment.
• 9 Company Paid Holidays (72 hours) each year.
• Uniforms Provided
• Foot Protection- annual allowance for all laboratory, maintenance and production employees.
• 24-hour access to our free, on-site fitness center.
• We provide Individual development, on-the-job training, and development programs designed to enhance your professional growth and development while ensuring you feel valued, inspired and appreciated at work.

Jost Chemical is an equal opportunity employer and affirmatively seeks diversity in its workforce. We consider applicants, and make all employment decisions, without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, or any other legally protected status. We are committed to recruiting and retaining the best talent in the chemical manufacturing industry.

Regulatory Affairs Specialist

Tasks

• Maintain current DMF/ASMF filings
• Respond to FDA and customer questions regarding content of DMF/ASMF filings and status.
• Prepare dossiers for new products various industries (NDIN, Novel Foods, DMF/ASMF, CEP, etc).
• Maintain required active registration status for the site and its products (Site Registration, Drug Listing, Food Facility Registration).
• Support sales and customer requests for information on compliance status of products.
• Work with Manufacturing, Sales and Marketing, Research and Development functions to assure FDA and other regulatory compliance requirements are incorporated as part of development process for new products.
• Assist contracted regulatory partners in information gathering and dossier submissions as needed.
• Assist in interpreting new and existing FDA and international regulations and guidance documents to assure compliance in company products and procedures.
• Maintain current knowledge of industry practices and regulations related to company products, both in US and internationally.
• Maintain and enhance site safety.
• Other duties as assigned.

Specifications

• B.S. in Chemistry, Biology, Biochemistry, or any other Scientific discipline
• At least (5) years of regulatory or quality experience in a cGMP manufacturing environment
• Knowledge of:
  • cGMP regulations / ICH Q7A (Broad level)
  • FDA and other US regulations (Broad level)
  • European Regulations
  • DMF/ASMF submissions
  • eCTD
  • REACH
  • Basic mathematics
  • MS Office software package (Broad level)
  • Operational Excellence methodologies
• Skill in:
  • Chemistry
  • Technical writing
  • Research of industry regulations
• Reading and understanding regulations and industry guidance with strong attention to detail
• Logical reasoning
• Working effectively and efficiently on multiple projects at once
• Working effectively in a team environment
• Responding to rapidly changing demands
• Ability to:
  • Perform customer, organizational and regulatory compliance activities
  • Communicate effectively, orally and in writing
  • Review, compile and verify technical data and documents
  • Identify, gather, process and record data accurately
  • Present information in an organized manner
  • Work independently

Position Details

• Reports to Regulatory Supervisor
• First shift, full time, salaried position

FLSA

• Exempt

Current Openings for Regulatory Affairs Specialist Jobs at Jost Chemical Co.