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Regulatory Affairs Associate

2 weeks ago

North Chicago, IL, United States Synectics Full time

Job Duties:

  • Responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.
  • This position will coordinate activities with all functional departments in support of regulatory filings.
  • Responsible for managing and compiling CMC sections of marketed product variations.
  • Partner with RA CMC Project Leads and develop module 3 content and project timelines.
  • Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
  • Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
  • Skills for running review meetings for submission documents.
  • Understand CMC expectations including CTD content, structural and formatting requirements.
  • Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
  • Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
  • Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
  • Review/approval of engineering study protocols/reports and validation study protocols/reports.
  • Review and approval of manufacturing changes for Class III implantable medical devices.
  • May lead and direct the work of others.
  • Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
  • Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
  • Independently facilitate project team meetings.
Qualifications :
  • Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
  • Required Experience: 1-2 years pharmaceutical; 1-2 years cross functional project management
  • Preferred Experience: 1-2 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
  • May require an advanced degree and 1-3 years of direct experience in the field.
  • Superior oral and written communication skills
  • Ability to work cooperatively with all levels and types of global personnel required
  • Experience working with electronic document management systems
  • Ability to work independently. Manage multiple projects simultaneously.
  • Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.
  • Detail/accuracy oriented, collaborative and willing to learn
  • Familiarity with US and other international regulatory requirements for dossiers
  • Recent experience with Class III implantable medical devices
  • Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.