Katalyst CRO
Join to apply for the
Regulatory Affairs Manager
role at
Katalyst CRO Continue with Google Continue with Google 3 weeks ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Manager
role at
Katalyst CRO However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs. This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements, and may support business development activities. Recognize, exemplify, and adhere to ICON's values which centre around our commitment to People, Clients and Performance. Work closely with Supply Chain, Project Management, QA teams to identify process and procedure improvements and assist in implementation of continuous. improvement measures to ensure dept expertise and to meet department goals. Identify issues and address them in a timely manner, including preventive actions. Keep abreast of regulatory procedures and changes to standards and Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements. Initiate regulatory submission when required and support ICON team with Regulatory Inspections. Effectively contribute to all the aspects of allocated projects in timely manner including, proactive identification of risks, scope change, regulatory implications for approval by VP/Directors. Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required. Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken. To be familiar with and to work in accordance with relevant ICON SOP's and internal systems, appropriate regulations and guidelines. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Responsibilities
However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs. This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements, and may support business development activities. Recognize, exemplify, and adhere to ICON's values which centre around our commitment to People, Clients and Performance. Work closely with Supply Chain, Project Management, QA teams to identify process and procedure improvements and assist in implementation of continuous. improvement measures to ensure dept expertise and to meet department goals. Identify issues and address them in a timely manner, including preventive actions. Keep abreast of regulatory procedures and changes to standards and Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements. Initiate regulatory submission when required and support ICON team with Regulatory Inspections. Effectively contribute to all the aspects of allocated projects in timely manner including, proactive identification of risks, scope change, regulatory implications for approval by VP/Directors. Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required. Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken. To be familiar with and to work in accordance with relevant ICON SOP's and internal systems, appropriate regulations and guidelines. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Requirements:
FDA 510K, FDA QSR (3+ years' experience). Excellent written and oral communication skills Good written and spoken English. Strong technical writing and editing skills. Travel (approximately 10-20%) domestic and/or international. 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 Manager jobs in
Cambridge, MA . Global Regulatory Affairs Chief of Staff
Boston, MA $208,200 - $327,140 2 weeks ago Senior Regulatory Affairs Specialist (Memphis, TN)
Senior Regulatory Affairs Specialist (Memphis, TN)
Senior Manager, Regulatory Affairs, Operations
Associate Director/Director of Regulatory Affairs
Sr Regulatory Affairs Specialist (Remote) - Shockwave
Boston, MA $89,000.00 - $165,600.00 1 day ago Boston, MA $135,000.00 - $165,000.00 2 weeks ago Cambridge, MA $127,219.00 - $190,828.00 2 weeks ago Greater Boston $172,521.00 - $249,862.00 1 day ago Associate Director, Global Regulatory Affairs
Boston, MA $153,600.00 - $241,340.00 2 weeks ago Sr. Regulatory Affairs Specialist (Austin, TX)
Boston, MA $165,000 - $200,000 4 weeks ago Associate Director, Regulatory Affairs Strategy
Cambridge, MA $149,069 - $223,604 2 weeks ago Sr. Manager, Global Regulatory Publishing
Manager, External and Regulatory Affairs
Associate Director, Global Regulatory Affairs, Advertising and Promotion
Associate Director CMC Regulatory Affairs
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
Regulatory Affairs Manager
role at
Katalyst CRO Continue with Google Continue with Google 3 weeks ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Manager
role at
Katalyst CRO However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs. This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements, and may support business development activities. Recognize, exemplify, and adhere to ICON's values which centre around our commitment to People, Clients and Performance. Work closely with Supply Chain, Project Management, QA teams to identify process and procedure improvements and assist in implementation of continuous. improvement measures to ensure dept expertise and to meet department goals. Identify issues and address them in a timely manner, including preventive actions. Keep abreast of regulatory procedures and changes to standards and Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements. Initiate regulatory submission when required and support ICON team with Regulatory Inspections. Effectively contribute to all the aspects of allocated projects in timely manner including, proactive identification of risks, scope change, regulatory implications for approval by VP/Directors. Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required. Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken. To be familiar with and to work in accordance with relevant ICON SOP's and internal systems, appropriate regulations and guidelines. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Responsibilities
However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs. This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements, and may support business development activities. Recognize, exemplify, and adhere to ICON's values which centre around our commitment to People, Clients and Performance. Work closely with Supply Chain, Project Management, QA teams to identify process and procedure improvements and assist in implementation of continuous. improvement measures to ensure dept expertise and to meet department goals. Identify issues and address them in a timely manner, including preventive actions. Keep abreast of regulatory procedures and changes to standards and Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements. Initiate regulatory submission when required and support ICON team with Regulatory Inspections. Effectively contribute to all the aspects of allocated projects in timely manner including, proactive identification of risks, scope change, regulatory implications for approval by VP/Directors. Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required. Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken. To be familiar with and to work in accordance with relevant ICON SOP's and internal systems, appropriate regulations and guidelines. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Requirements:
FDA 510K, FDA QSR (3+ years' experience). Excellent written and oral communication skills Good written and spoken English. Strong technical writing and editing skills. Travel (approximately 10-20%) domestic and/or international. 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 Manager jobs in
Cambridge, MA . Global Regulatory Affairs Chief of Staff
Boston, MA $208,200 - $327,140 2 weeks ago Senior Regulatory Affairs Specialist (Memphis, TN)
Senior Regulatory Affairs Specialist (Memphis, TN)
Senior Manager, Regulatory Affairs, Operations
Associate Director/Director of Regulatory Affairs
Sr Regulatory Affairs Specialist (Remote) - Shockwave
Boston, MA $89,000.00 - $165,600.00 1 day ago Boston, MA $135,000.00 - $165,000.00 2 weeks ago Cambridge, MA $127,219.00 - $190,828.00 2 weeks ago Greater Boston $172,521.00 - $249,862.00 1 day ago Associate Director, Global Regulatory Affairs
Boston, MA $153,600.00 - $241,340.00 2 weeks ago Sr. Regulatory Affairs Specialist (Austin, TX)
Boston, MA $165,000 - $200,000 4 weeks ago Associate Director, Regulatory Affairs Strategy
Cambridge, MA $149,069 - $223,604 2 weeks ago Sr. Manager, Global Regulatory Publishing
Manager, External and Regulatory Affairs
Associate Director, Global Regulatory Affairs, Advertising and Promotion
Associate Director CMC Regulatory Affairs
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