Katalyst CRO
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Regulatory Affairs Manager
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Katalyst CRO 7 months ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Manager
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre- and post- submission. This role is critical in ensuring that products meet all regulatory requirements and meet the regulatory standards of FDAs Office of Generic Drugs. The ideal candidate will have a deep understanding of regulatory affairs related to generic drug development and dossier submission, excellent leadership skills, and a proven track record of successful regulatory submissions and interactions with regulatory agencies. Develop and implement regulatory strategies for generic product development, product modifications, and lifecycle management. Ensure all regulatory activities align with company goals and compliance requirements Monitor and interpret regulatory changes and trends to ensure ongoing agreement with regulatory guidance. Actively participate in the preparation, submission, and management of regulatory filings, primarily focusing on ANDAs submitted to FDA. Prepare, review and submit Controlled Correspondences to FDA. Manage regulatory correspondence in the US (OGD, User fee staff, drug listing), and EU/UK Agencies as needed. Participate in, and oversee the preparation of dossiers with external vendor, and ensure they meet regulatory standards and guidelines. Coordinate with cross-functional teams to compile and review submission materials. Preparation, submission and monitoring of PLAIR activities, prior to new product launch. Manage ANDA Labelling activities. Serve as the primary liaison with regulatory authorities. Manage and facilitate meetings and communications with regulatory agencies. Address regulatory queries and issues promptly and effectively. Collaborate with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are integrated into product development and lifecycle processes. Conduct regulatory intelligence to anticipate and address potential regulatory challenges. Develop and implement risk management strategies to address regulatory compliance issues. Documentation and Reporting. Maintain accurate and up-to-date regulatory files and documentation. Prepare and present regulatory updates and reports to senior management and other stakeholders.
Responsibilities
The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre- and post- submission. This role is critical in ensuring that products meet all regulatory requirements and meet the regulatory standards of FDAs Office of Generic Drugs. The ideal candidate will have a deep understanding of regulatory affairs related to generic drug development and dossier submission, excellent leadership skills, and a proven track record of successful regulatory submissions and interactions with regulatory agencies. Develop and implement regulatory strategies for generic product development, product modifications, and lifecycle management. Ensure all regulatory activities align with company goals and compliance requirements Monitor and interpret regulatory changes and trends to ensure ongoing agreement with regulatory guidance. Actively participate in the preparation, submission, and management of regulatory filings, primarily focusing on ANDAs submitted to FDA. Prepare, review and submit Controlled Correspondences to FDA. Manage regulatory correspondence in the US (OGD, User fee staff, drug listing), and EU/UK Agencies as needed. Participate in, and oversee the preparation of dossiers with external vendor, and ensure they meet regulatory standards and guidelines. Coordinate with cross-functional teams to compile and review submission materials. Preparation, submission and monitoring of PLAIR activities, prior to new product launch. Manage ANDA Labelling activities. Serve as the primary liaison with regulatory authorities. Manage and facilitate meetings and communications with regulatory agencies. Address regulatory queries and issues promptly and effectively. Collaborate with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are integrated into product development and lifecycle processes. Conduct regulatory intelligence to anticipate and address potential regulatory challenges. Develop and implement risk management strategies to address regulatory compliance issues. Documentation and Reporting. Maintain accurate and up-to-date regulatory files and documentation. Prepare and present regulatory updates and reports to senior management and other stakeholders.
Requirements
Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry. In-depth knowledge of OGD regulatory requirements and standards. Proven experience with regulatory submissions and interactions with regulatory agencies. Self-starter with strong hands-on experience. Strong leadership, communication, and interpersonal skills. Ability to work effectively in a fast-paced and dynamic environment. Excellent organizational and project management skills. 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 Sign in to set job alerts for Regulatory Affairs Manager roles.
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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
Regulatory Affairs Manager
role at
Katalyst CRO 7 months ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Manager
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre- and post- submission. This role is critical in ensuring that products meet all regulatory requirements and meet the regulatory standards of FDAs Office of Generic Drugs. The ideal candidate will have a deep understanding of regulatory affairs related to generic drug development and dossier submission, excellent leadership skills, and a proven track record of successful regulatory submissions and interactions with regulatory agencies. Develop and implement regulatory strategies for generic product development, product modifications, and lifecycle management. Ensure all regulatory activities align with company goals and compliance requirements Monitor and interpret regulatory changes and trends to ensure ongoing agreement with regulatory guidance. Actively participate in the preparation, submission, and management of regulatory filings, primarily focusing on ANDAs submitted to FDA. Prepare, review and submit Controlled Correspondences to FDA. Manage regulatory correspondence in the US (OGD, User fee staff, drug listing), and EU/UK Agencies as needed. Participate in, and oversee the preparation of dossiers with external vendor, and ensure they meet regulatory standards and guidelines. Coordinate with cross-functional teams to compile and review submission materials. Preparation, submission and monitoring of PLAIR activities, prior to new product launch. Manage ANDA Labelling activities. Serve as the primary liaison with regulatory authorities. Manage and facilitate meetings and communications with regulatory agencies. Address regulatory queries and issues promptly and effectively. Collaborate with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are integrated into product development and lifecycle processes. Conduct regulatory intelligence to anticipate and address potential regulatory challenges. Develop and implement risk management strategies to address regulatory compliance issues. Documentation and Reporting. Maintain accurate and up-to-date regulatory files and documentation. Prepare and present regulatory updates and reports to senior management and other stakeholders.
Responsibilities
The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre- and post- submission. This role is critical in ensuring that products meet all regulatory requirements and meet the regulatory standards of FDAs Office of Generic Drugs. The ideal candidate will have a deep understanding of regulatory affairs related to generic drug development and dossier submission, excellent leadership skills, and a proven track record of successful regulatory submissions and interactions with regulatory agencies. Develop and implement regulatory strategies for generic product development, product modifications, and lifecycle management. Ensure all regulatory activities align with company goals and compliance requirements Monitor and interpret regulatory changes and trends to ensure ongoing agreement with regulatory guidance. Actively participate in the preparation, submission, and management of regulatory filings, primarily focusing on ANDAs submitted to FDA. Prepare, review and submit Controlled Correspondences to FDA. Manage regulatory correspondence in the US (OGD, User fee staff, drug listing), and EU/UK Agencies as needed. Participate in, and oversee the preparation of dossiers with external vendor, and ensure they meet regulatory standards and guidelines. Coordinate with cross-functional teams to compile and review submission materials. Preparation, submission and monitoring of PLAIR activities, prior to new product launch. Manage ANDA Labelling activities. Serve as the primary liaison with regulatory authorities. Manage and facilitate meetings and communications with regulatory agencies. Address regulatory queries and issues promptly and effectively. Collaborate with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are integrated into product development and lifecycle processes. Conduct regulatory intelligence to anticipate and address potential regulatory challenges. Develop and implement risk management strategies to address regulatory compliance issues. Documentation and Reporting. Maintain accurate and up-to-date regulatory files and documentation. Prepare and present regulatory updates and reports to senior management and other stakeholders.
Requirements
Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry. In-depth knowledge of OGD regulatory requirements and standards. Proven experience with regulatory submissions and interactions with regulatory agencies. Self-starter with strong hands-on experience. Strong leadership, communication, and interpersonal skills. Ability to work effectively in a fast-paced and dynamic environment. Excellent organizational and project management skills. 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 Sign in to set job alerts for Regulatory Affairs Manager roles.
Global Regulatory Affairs Chief of Staff
Boston, MA $208,200.00-$327,140.00 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 (Hyrbid)
Massachusetts, United States $89,400.00-$134,100.00 4 days ago 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 3 weeks ago Greater Boston $172,521.00-$249,862.00 2 days ago Associate Director, Global Regulatory Affairs
Boston, MA $153,600.00-$241,340.00 2 weeks ago Sr. Regulatory Affairs Specialist (Austin, TX)
Associate Director, Regulatory Affairs Strategy
Cambridge, MA $149,069.00-$223,604.00 3 weeks ago Sr. Manager, Global Regulatory Publishing
Manager, External and Regulatory Affairs
Associate Director, Global Regulatory Affairs, Advertising and Promotion
Boston, MA $153,600.00-$241,340.00 2 weeks ago Associate Director CMC Regulatory Affairs
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr