Regulatory Affairs Associate

Spectraforce Technologies, Inc.; North Chicago (IL); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Spectraforce Technologies, Inc. in North Chicago, IL is seeking a Regulatory Affairs Associate to manage CMC sections for marketed product variations and develop CTD Module 3 content. The role partners with RA CMC leads and diverse functional groups to ensure timely, accurate filings.

The candidate will file PMA supplements, review engineering and manufacturing change documents, and lead cross-functional teams while keeping up with US and international regulatory requirements.

Qualifications

• Bachelor's degree in a chemical or biological discipline is required.
• Pharmaceutical regulatory affairs experience is essential.
• Experience coordinating cross-functional teams and project timelines is preferred.

Responsibilities

• Manage and compile CMC sections of marketed product variations for timely submissions.
• Coordinate activities with all functional departments to support regulatory filings.
• Author and assemble CTD Module 3 content and ensure formatting requirements are met.
• Lead and facilitate project team meetings with minimal oversight.
• Maintain awareness of regulatory requirements for US and international dossiers.

Skills

Regulatory Affairs

CMC

Project Management

Cross-functional

Documentation

Education

BA/BS in Chemical or Biological Sciences

Tools

Electronic Document Management Systems

Job description

Job Title: Regulatory Affairs Associate

Duration: 5 months

Location: North Chicago, IL – Hybrid – (Tues - Thurs onsite); 60064

Description:

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.

Reponsibilities:

Individual 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.

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.

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

Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline

Required Experience: 4 years pharmaceutical. 1-2 years cross functional project management

Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)

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 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. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected.

Experience Level = 1-3 Years