Planet Pharma
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Regulatory Affairs Associate I
role at
Planet Pharma Join to apply for the
Regulatory Affairs Associate I
role at
Planet Pharma Job Description
Target PR Range: 28-38/hr
Depending on experience
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: 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)
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 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 The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Legal Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Sign in to set job alerts for “Regulatory Affairs Associate” roles.
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Regulatory Affairs Associate I
role at
Planet Pharma Join to apply for the
Regulatory Affairs Associate I
role at
Planet Pharma Job Description
Target PR Range: 28-38/hr
Depending on experience
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: 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)
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 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 The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Legal Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Sign in to set job alerts for “Regulatory Affairs Associate” roles.
Northfield, IL $79,560 - $115,440 2 weeks ago Northfield, IL $79,560 - $115,440 2 weeks ago Lake Forest, IL $63,750.00 - $91,375.00 3 days ago Regulatory Affairs Project Lead - 247670
Buffalo Grove, IL $75,000.00 - $90,000.00 17 hours ago 2026 Regulatory Affairs U.S. Advertising and Promotion Intern (PharmD)
Buffalo Grove, IL $70,000.00 - $75,000.00 1 month ago Northfield, IL $96,200.00 - $144,560.00 2 weeks ago Regulatory Affairs Lead, Oncology (Sr. Manager)
Northbrook, IL $130,000.00 - $170,000.00 1 week ago Niles, IL $75,000.00 - $90,000.00 2 months ago Lead, Regulatory Affairs Advertising & Promotion
Northbrook, IL $120,000.00 - $150,000.00 1 week ago Deerfield, IL $136,000.00 - $187,000.00 2 months ago Associate Director, Regulatory Affairs CMC - Hybrid Onsite
North Chicago, IL $137,500.00 - $261,000.00 3 days ago Senior Manager Regulatory Affairs - Labeling, Advertising and Promotions (Remote)
Des Plaines, IL $160,000.00 - $200,000.00 3 days ago 2026 Regulatory Affairs U.S. Advertising and Promotion Intern (PharmD)
2026 Clinical Trial Operations Development Program
North Chicago, IL $64,000 - $122,000 1 week ago North Chicago, IL $20.30 - $36.50 2 weeks ago Associate Director, Regulatory Affairs CMC - Hybrid Onsite
Diagnostic Regulatory Strategy Lead (CDx) (Associate Director)
Northbrook, IL $150,000 - $195,000 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr