Katalyst CRO
Join to apply for the
Regulatory Affairs Specialist
role at
Katalyst CRO Join to apply for the
Regulatory Affairs Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval. This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. This role will build and maintain relationships with scientific staff, lab champions, functional heads, leadership, and support services to foster trust, facilitate solutions, on all assigned operations. They will facilitate efforts to overcome the obstacles and major roadblocks so scientists can succeed, while empowering them to function independently within the current operational workflows. They will review the scope of the various support services to identify gaps and solutions based on the requirements of the site. Facilitate coordination of disruptive activities required by workplace experience, real estate, or other initiatives coordinate to ensure science continuation. Manage office and lab basic consumables including issuing PO's, tracking and invoice approvals, receiving, handling, & stocking.
Responsibilities
The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval. This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. This role will build and maintain relationships with scientific staff, lab champions, functional heads, leadership, and support services to foster trust, facilitate solutions, on all assigned operations. They will facilitate efforts to overcome the obstacles and major roadblocks so scientists can succeed, while empowering them to function independently within the current operational workflows. They will review the scope of the various support services to identify gaps and solutions based on the requirements of the site. Facilitate coordination of disruptive activities required by workplace experience, real estate, or other initiatives coordinate to ensure science continuation. Manage office and lab basic consumables including issuing PO's, tracking and invoice approvals, receiving, handling, & stocking.
Requirements:
BS required in Life Science discipline or engineering. Experience working with GXP integrated commissioning and qualification practices Experience working within a regulated environment. Experience with coordinating invasive operations from managing large capital projects/investments. Solid understanding of Health, Safety, Environmental and Legal requirements for operations. Clear operational experience in R&D and development laboratories. Excellent communication and technical writing skills. Demonstrated problem solving / trouble shooting skills. Direct experience working in regulated environments, i.e., cGMP, OSHA, EPA, etc Proficiency with Microsoft Office Suite, working knowledge of common intranet communication tools and business tools such as Concur, eBuy, EasyInvoice, and Workday. Ability to grow and gain entry to laboratory, manufacturing, and mechanical areas. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
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Regulatory Affairs Specialist
role at
Katalyst CRO Join to apply for the
Regulatory Affairs Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval. This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. This role will build and maintain relationships with scientific staff, lab champions, functional heads, leadership, and support services to foster trust, facilitate solutions, on all assigned operations. They will facilitate efforts to overcome the obstacles and major roadblocks so scientists can succeed, while empowering them to function independently within the current operational workflows. They will review the scope of the various support services to identify gaps and solutions based on the requirements of the site. Facilitate coordination of disruptive activities required by workplace experience, real estate, or other initiatives coordinate to ensure science continuation. Manage office and lab basic consumables including issuing PO's, tracking and invoice approvals, receiving, handling, & stocking.
Responsibilities
The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval. This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. This role will build and maintain relationships with scientific staff, lab champions, functional heads, leadership, and support services to foster trust, facilitate solutions, on all assigned operations. They will facilitate efforts to overcome the obstacles and major roadblocks so scientists can succeed, while empowering them to function independently within the current operational workflows. They will review the scope of the various support services to identify gaps and solutions based on the requirements of the site. Facilitate coordination of disruptive activities required by workplace experience, real estate, or other initiatives coordinate to ensure science continuation. Manage office and lab basic consumables including issuing PO's, tracking and invoice approvals, receiving, handling, & stocking.
Requirements:
BS required in Life Science discipline or engineering. Experience working with GXP integrated commissioning and qualification practices Experience working within a regulated environment. Experience with coordinating invasive operations from managing large capital projects/investments. Solid understanding of Health, Safety, Environmental and Legal requirements for operations. Clear operational experience in R&D and development laboratories. Excellent communication and technical writing skills. Demonstrated problem solving / trouble shooting skills. Direct experience working in regulated environments, i.e., cGMP, OSHA, EPA, etc Proficiency with Microsoft Office Suite, working knowledge of common intranet communication tools and business tools such as Concur, eBuy, EasyInvoice, and Workday. Ability to grow and gain entry to laboratory, manufacturing, and mechanical areas. Seniority level
Seniority level Mid-Senior level 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 Specialist jobs in
Waltham, MA . Cambridge, MA $128,520.00-$205,632.00 1 week ago Compliance Associate, Financial Regulatory Affairs
Boston, MA $74,200.00-$126,200.00 3 days ago Senior Regulatory Affairs Specialist (Memphis, TN)
Sr Regulatory Affairs Specialist (Remote) - Shockwave
Boston, MA $89,000.00-$165,600.00 2 days ago Senior Regulatory Affairs Specialist (Memphis, TN)
Sr. Regulatory Affairs Specialist (Hyrbid)
Massachusetts, United States $89,400.00-$134,100.00 4 days ago Compliance Associate, Financial Regulatory Affairs
Boston, MA $74,200.00-$126,200.00 2 days ago Global Regulatory Affairs Chief of Staff
Boston, MA $208,200.00-$327,140.00 2 weeks ago Regulatory Affairs CMC Expert - Biologics
Associate Director/Director of Regulatory Affairs
Cambridge, MA $127,219.00-$190,828.00 3 weeks ago Senior Manager, Regulatory Affairs, Operations
Associate Director, Global Regulatory Affairs
Boston, MA $153,600.00-$241,340.00 2 weeks 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