Katalyst CRO
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Senior Regulatory Affairs Manager
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Katalyst CRO 3 days ago Be among the first 25 applicants Join to apply for the
Senior Regulatory Affairs Manager
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Katalyst CRO Support the Senior Director in developing and executing regional regulatory strategies for QOL. initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements. Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities. Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes. Assist in fostering relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to QOL initiatives. Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director and Associate Director. Contribute to managing regulatory risks and opportunities related to QOL initiatives and assist in developing mitigation strategies as needed. Provide regulatory guidance and support for post-marketing activities related to QOL initiatives, Including variations, renewals, labeling updates, and compliance initiatives. Collaborate with the regulatory team to represent the company's interests in industry forums, working groups, and regulatory meetings related to QOL initiatives. Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives. Assist in preparing regulatory updates, progress reports, and strategic recommendations for senior and/or executive leadership and regulatory governance committees. Assists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness, accuracy, and accessibility of records related to QOL initiatives. Participates in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner.
Responsibilities
Support the Senior Director in developing and executing regional regulatory strategies for QOL. initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements. Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities. Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes. Assist in fostering relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to QOL initiatives. Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director and Associate Director. Contribute to managing regulatory risks and opportunities related to QOL initiatives and assist in developing mitigation strategies as needed. Provide regulatory guidance and support for post-marketing activities related to QOL initiatives, Including variations, renewals, labeling updates, and compliance initiatives. Collaborate with the regulatory team to represent the company's interests in industry forums, working groups, and regulatory meetings related to QOL initiatives. Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives. Assist in preparing regulatory updates, progress reports, and strategic recommendations for senior and/or executive leadership and regulatory governance committees. Assists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness, accuracy, and accessibility of records related to QOL initiatives. Participates in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner.
Requirements
Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred. 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on quality-of-life products preferred. Must have branded product reg affairs experience. Demonstrated ability to work effectively in a cross-functional team environment. Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills. Ability to assist in developing and executing regulatory strategies tailored to specific regions. Strong organizational skills with attention to detail. Ability to collaborate effectively with cross-functional teams. Knowledge of regulatory submissions and documentation processes. Awareness of regulatory developments and trends within specific regions. Strong analytical and problem-solving skills. Ability to work independently and prioritize tasks effectively. Ability and willingness to travel approximately 10% of the year both domestically and internationally. 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 Senior Manager Regulatory Affairs roles.
Director, Regulatory Affairs (Transfusion)
Director Life Sciences Regulatory Affairs and Labeling
Senior Regulatory Affairs Manager (Onsite)
Senior Regulatory Affairs Manager (Onsite)
Associate Regulatory Affairs Manager (Atlanta)
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Senior Regulatory Affairs Manager
role at
Katalyst CRO 3 days ago Be among the first 25 applicants Join to apply for the
Senior Regulatory Affairs Manager
role at
Katalyst CRO Support the Senior Director in developing and executing regional regulatory strategies for QOL. initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements. Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities. Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes. Assist in fostering relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to QOL initiatives. Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director and Associate Director. Contribute to managing regulatory risks and opportunities related to QOL initiatives and assist in developing mitigation strategies as needed. Provide regulatory guidance and support for post-marketing activities related to QOL initiatives, Including variations, renewals, labeling updates, and compliance initiatives. Collaborate with the regulatory team to represent the company's interests in industry forums, working groups, and regulatory meetings related to QOL initiatives. Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives. Assist in preparing regulatory updates, progress reports, and strategic recommendations for senior and/or executive leadership and regulatory governance committees. Assists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness, accuracy, and accessibility of records related to QOL initiatives. Participates in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner.
Responsibilities
Support the Senior Director in developing and executing regional regulatory strategies for QOL. initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements. Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities. Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes. Assist in fostering relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to QOL initiatives. Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director and Associate Director. Contribute to managing regulatory risks and opportunities related to QOL initiatives and assist in developing mitigation strategies as needed. Provide regulatory guidance and support for post-marketing activities related to QOL initiatives, Including variations, renewals, labeling updates, and compliance initiatives. Collaborate with the regulatory team to represent the company's interests in industry forums, working groups, and regulatory meetings related to QOL initiatives. Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives. Assist in preparing regulatory updates, progress reports, and strategic recommendations for senior and/or executive leadership and regulatory governance committees. Assists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness, accuracy, and accessibility of records related to QOL initiatives. Participates in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner.
Requirements
Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred. 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on quality-of-life products preferred. Must have branded product reg affairs experience. Demonstrated ability to work effectively in a cross-functional team environment. Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. Excellent communication and interpersonal skills. Ability to assist in developing and executing regulatory strategies tailored to specific regions. Strong organizational skills with attention to detail. Ability to collaborate effectively with cross-functional teams. Knowledge of regulatory submissions and documentation processes. Awareness of regulatory developments and trends within specific regions. Strong analytical and problem-solving skills. Ability to work independently and prioritize tasks effectively. Ability and willingness to travel approximately 10% of the year both domestically and internationally. 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 Senior Manager Regulatory Affairs roles.
Director, Regulatory Affairs (Transfusion)
Director Life Sciences Regulatory Affairs and Labeling
Senior Regulatory Affairs Manager (Onsite)
Senior Regulatory Affairs Manager (Onsite)
Associate Regulatory Affairs Manager (Atlanta)
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr