Katalyst CRO
Global Regulatory Affairs Manager
Katalyst CRO, Raleigh, North Carolina, United States, 27601
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Global Regulatory Affairs Manager
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Katalyst CRO 7 months ago Be among the first 25 applicants Join to apply for the
Global Regulatory Affairs Manager
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Katalyst CRO The Global RA Manager supports the Global Regulatory Teams in the translation of regulatory requirements into practical application to ensure the success of pre-approval drug development programs. Supports regulatory agency interactions, communications, and preparation of submissions. Independently coordinates the request to Affiliates and Partners of the regulatory requirements applicable to supported regions or areas of responsibility. With guidance from Unit Head, assist in the identification of the EU and US regulatory requirements applicable to supported regions or areas of responsibility. With guidance from Unit Head, assist in the preparation and presentation of regulatory information at internal project meetings; Contribute to global strategy via participation in GRT. With limited assistance, confirm compliance with applicable regulations and guidelines to ensure suitability of regulatory applications for submission. Provide updates to internal documentation, as appropriate. With guidance, provides support to GMP, GCP, and GPV inspections from health authorities. With guidance supports pre-approval and post approval activities. With guidance maintains relationships with the health authorities, directly or via Affiliate/Partners. With guidance manages IMDD, Affiliate, and Partner relationship(s) to ensure efficient global execution.
Responsibilities
The Global RA Manager supports the Global Regulatory Teams in the translation of regulatory requirements into practical application to ensure the success of pre-approval drug development programs. Supports regulatory agency interactions, communications, and preparation of submissions. Independently coordinates the request to Affiliates and Partners of the regulatory requirements applicable to supported regions or areas of responsibility. With guidance from Unit Head, assist in the identification of the EU and US regulatory requirements applicable to supported regions or areas of responsibility. With guidance from Unit Head, assist in the preparation and presentation of regulatory information at internal project meetings; Contribute to global strategy via participation in GRT. With limited assistance, confirm compliance with applicable regulations and guidelines to ensure suitability of regulatory applications for submission. Provide updates to internal documentation, as appropriate. With guidance, provides support to GMP, GCP, and GPV inspections from health authorities. With guidance supports pre-approval and post approval activities. With guidance maintains relationships with the health authorities, directly or via Affiliate/Partners. With guidance manages IMDD, Affiliate, and Partner relationship(s) to ensure efficient global execution.
Requirements:
University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology. Scientific secondary-school diploma with at least 7 years of experience within International Regulatory Affairs. At least 5 years of experience in Regulatory Affairs. General knowledge of the drug development process, of drug regulations, regulatory procedures, and drug development guidance Good knowledge of regulatory tools for tracking and archiving. Good knowledge of the basic Office programs. Ability to prepare PowerPoint presentations. Ability to search and retrieve information from the worldwide web. 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 Sign in to set job alerts for “Regulatory Affairs Manager” roles.
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Global Regulatory Affairs Manager
role at
Katalyst CRO 7 months ago Be among the first 25 applicants Join to apply for the
Global Regulatory Affairs Manager
role at
Katalyst CRO The Global RA Manager supports the Global Regulatory Teams in the translation of regulatory requirements into practical application to ensure the success of pre-approval drug development programs. Supports regulatory agency interactions, communications, and preparation of submissions. Independently coordinates the request to Affiliates and Partners of the regulatory requirements applicable to supported regions or areas of responsibility. With guidance from Unit Head, assist in the identification of the EU and US regulatory requirements applicable to supported regions or areas of responsibility. With guidance from Unit Head, assist in the preparation and presentation of regulatory information at internal project meetings; Contribute to global strategy via participation in GRT. With limited assistance, confirm compliance with applicable regulations and guidelines to ensure suitability of regulatory applications for submission. Provide updates to internal documentation, as appropriate. With guidance, provides support to GMP, GCP, and GPV inspections from health authorities. With guidance supports pre-approval and post approval activities. With guidance maintains relationships with the health authorities, directly or via Affiliate/Partners. With guidance manages IMDD, Affiliate, and Partner relationship(s) to ensure efficient global execution.
Responsibilities
The Global RA Manager supports the Global Regulatory Teams in the translation of regulatory requirements into practical application to ensure the success of pre-approval drug development programs. Supports regulatory agency interactions, communications, and preparation of submissions. Independently coordinates the request to Affiliates and Partners of the regulatory requirements applicable to supported regions or areas of responsibility. With guidance from Unit Head, assist in the identification of the EU and US regulatory requirements applicable to supported regions or areas of responsibility. With guidance from Unit Head, assist in the preparation and presentation of regulatory information at internal project meetings; Contribute to global strategy via participation in GRT. With limited assistance, confirm compliance with applicable regulations and guidelines to ensure suitability of regulatory applications for submission. Provide updates to internal documentation, as appropriate. With guidance, provides support to GMP, GCP, and GPV inspections from health authorities. With guidance supports pre-approval and post approval activities. With guidance maintains relationships with the health authorities, directly or via Affiliate/Partners. With guidance manages IMDD, Affiliate, and Partner relationship(s) to ensure efficient global execution.
Requirements:
University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology. Scientific secondary-school diploma with at least 7 years of experience within International Regulatory Affairs. At least 5 years of experience in Regulatory Affairs. General knowledge of the drug development process, of drug regulations, regulatory procedures, and drug development guidance Good knowledge of regulatory tools for tracking and archiving. Good knowledge of the basic Office programs. Ability to prepare PowerPoint presentations. Ability to search and retrieve information from the worldwide web. 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 Sign in to set job alerts for “Regulatory Affairs Manager” roles.
Sr Regulatory Affairs Specialist (Remote) - Shockwave
Raleigh, NC $89,000.00-$165,600.00 1 day ago Sr Regulatory Affairs Strategy Specialist
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Raleigh, NC $148,000.00-$200,000.00 2 days ago Senior Manager - Regulatory & Practice Review- Seasonal
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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