KIK Custom Products

Regulatory Compliance Specialist

Job Location US-TX-Ft. Worth
Posted Date 3 weeks ago(1/26/2018 2:45 PM)
Job ID
2018-4995
# of Openings
1
Division
KCM

Overview

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This position is responsible for understanding product requirements, driving and ensuring compliance with corresponding regulatory agencies.  This individual must be very detail oriented and an excellent  communicator as they work closely with our customers, suppliers and internal departments as well as external Regulators to ensure our products are in full regulatory compliance.  Key to landing this position is having Regulatory Compliance experience in a manufacturing environment that produces a variety of regulated products including OTC products, Pharmaceuticals, and Medical Devices.  CBI works with various regulatory bodies including FDA, EPA, ANVISA, ISO and other global regulatory bodies.

Essential Job Functions

  • Coordinate regulatory requirements to ensure compliance with the Food and Drug Administration (FDA) and international regulations and interpretations
  • Alert divisional leadership to issues and potential problems, delays and/or deficiencies, and make recommendations as appropriate
  • Schedule, track project/operational activities, such as labeling reviews and approvals.
  • Monitor various regulatory agency websites for new regulations, guidance documents and pertinent agency meetings
  • Prepare Regulatory Standard Operating Procedures and Work Procedures
  • Knowledge of FDA, Health Canada, EPA, ISO, ANVISA and other regulatory body regulations.
  • Knowledge of foreign regulations and ICH is a plus.
  • Able to review routine regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
  • Coordinate, prepare and submit necessary forms for product registration/notification with relevant authorities in the US, Canada and EU.
  • Coordinate, prepare and submit necessary forms for product registration/notification with relevant authorities in the US, Canada and EU.
  • Assist with the validation of local developments (e.g. accessories) to ensure compliance with regulatory and ethical/social standards
  • Review and interpret regulatory guidance’s including dissemination of the information to all affected parties within CBI and any affected clients
  • Independently prepare complete submissions – pre-IND, IND, Meeting Packets, NDA, ANDA, Annual Reports, and other product correspondence – and submitting said submission through the Electronic Submissions Gateway if required.
  • Review documents generated by other departments for submission-readiness
  • Assess filing impact of change controls and associated documents as well as conformance to submission requirements

 

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. 

Qualifications

  • Bachelor’s degree reqired.  Degree in chemistry or life sciences ideal.
  • Three years or more regulatory experience within the cosmetic or pharma industry.
  • RAC certification a plus but not required.
  • Detail Oriented and Self Motivated with strong written and verbal communication skills
  • Intermediate to Advanced experience in MS Office including Access and Excel
  • Experience in equipment validation an asset

 

 

Thank you for your interest and consideration of a career with KIK!

KIK is an Equal Opportunity / Affirmative Action employer.  Qualified applicants will receive consideration for employment without regards to race, color, religion, sex, or national origin.

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