Regulatory Affairs Associate I (Hybrid in Lake County, IL)

Regulatory Affairs Associate I
1 Year initial contract
Onsite - Lake County, IL (Hybrid – Tuesdays to Thursdays onsite)
Hourly Pay Rate: $27-30/hr (medical insurance benefits available at a cost)


The Regulatory Affairs Associate I is 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.


Responsibilities:

• 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.
• 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.
• 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.

Qualifications:

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
• Superior oral and written communication skills
• Familiarity with US and other international regulatory requirements for dossiers
• 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

Required Experience:

• 1-2 years pharmaceutical.
• 1-2 years cross functional project management
• May require an advanced degree and 1-3 years of direct experience in the field.
• 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
• Relies on extensive experience and judgment to plan and accomplish goals.
• May lead and direct the work of others.
• A wide degree of creativity and latitude is expected.

Preferred Experience:

• 1-2 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
• Skills for running review meetings for submission documents.
• Understand CMC expectations including CTD content, structural and formatting requirements.

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