Katalyst CRO
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CMC Regulatory Affairs Associate
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Katalyst CRO 22 hours ago Be among the first 25 applicants Join to apply for the
CMC Regulatory Affairs Associate
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. 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 3 to 5 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.
Responsibilities
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 3 to 5 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.
Requirements:
CMC (Chemistry, Manufacturing, Controls) background in completing clinical submissions. IND/IMPD submission background based on manufacturing batch records. Early Phase CMC knowledge a plus. French/ English speaking a plus. Experience Level = 3-5 Years. Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies. Technical writing skills. Familiar with typical manufacturing processes, especially cell cultures. Familiar with microbial methodology. Familiar with ICH and country regulatory procedures for clinical trials. Able to work with electronic systems i.e., Microsoft and dossier publication systems. New manufacturing site in France due to acquiring new business . Contractor needed to complete 3 separate projects for CMC clinical/regulatory submissions. This was a previous commitment for completion from prior company. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Legal Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Associate jobs in
North Chicago, IL . CMC Regulatory Affairs Associate II----Hybrid
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
CMC Regulatory Affairs Associate
role at
Katalyst CRO 22 hours ago Be among the first 25 applicants Join to apply for the
CMC Regulatory Affairs Associate
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. 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 3 to 5 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.
Responsibilities
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 3 to 5 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.
Requirements:
CMC (Chemistry, Manufacturing, Controls) background in completing clinical submissions. IND/IMPD submission background based on manufacturing batch records. Early Phase CMC knowledge a plus. French/ English speaking a plus. Experience Level = 3-5 Years. Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies. Technical writing skills. Familiar with typical manufacturing processes, especially cell cultures. Familiar with microbial methodology. Familiar with ICH and country regulatory procedures for clinical trials. Able to work with electronic systems i.e., Microsoft and dossier publication systems. New manufacturing site in France due to acquiring new business . Contractor needed to complete 3 separate projects for CMC clinical/regulatory submissions. This was a previous commitment for completion from prior company. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Legal Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Associate jobs in
North Chicago, IL . CMC Regulatory Affairs Associate II----Hybrid
Glenview, IL $80,000.00-$95,000.00 2 weeks ago Regulatory Affairs Specialist- Cosmetic/Drugs
Northfield, IL $79,560.00-$115,440.00 2 weeks ago Quality Assurance and Regulatory Affairs Manager
Niles, IL $75,000.00-$90,000.00 3 weeks ago Associate General Counsel - R&D Innovation Legal (Regulatory)
North Chicago, IL $177,000.00-$336,000.00 1 week ago Associate Director, Regulatory Affairs CMC (Hybrid Onsite)
North Chicago, IL $137,500.00-$261,000.00 1 week ago Lead, Regulatory Affairs Advertising & Promotion
Northbrook, IL $120,000.00-$150,000.00 5 days ago Senior Specialist, Regulatory Affairs (Advertising and Promotion),
Senior Specialist, Regulatory Affairs (Advertising and Promotion)
Deerfield, IL $80,000.00-$110,000.00 1 month ago Manager, Regulatory Affairs (Advertising and Promotion)
Deerfield, IL $112,000.00-$155,000.00 1 month ago Associate Director, Regulatory Affairs CMC (Hybrid Onsite)
Associate General Counsel - R&D Innovation Legal (Regulatory)
North Chicago, IL $177,000.00-$336,000.00 1 week ago Senior Manager RA US Advertising and Promotion - Allergan Aesthetics
North Chicago, IL $121,000.00-$230,000.00 2 weeks ago Senior Manager RA US Advertising and Promotion - Allergan Aesthetics
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr