Senior Regulatory Affairs Manager
1 day ago
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. + 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 % of the year both domestically and internationally.
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Regulatory Affairs Manager
1 week ago
Richmond Heights, United States The Tranzonic Companies Full timeRegulatory Affairs Manager – The Tranzonic Companies Company Overview Hospeco Brand Groups (Tranzonic Companies) is the hub for a strategic collection of manufacturing and sales companies that lead the way in multiple categories — from personal care and protection to textiles, from cleaning products to contamination control— to empower its distributor...
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Regulatory Affairs Manager
3 weeks ago
Richmond Heights, United States The Tranzonic Companies Full timeRegulatory Affairs Manager – The Tranzonic Companies Company Overview Hospeco Brand Groups (Tranzonic Companies) is the hub for a strategic collection of manufacturing and sales companies that lead the way in multiple categories — from personal care and protection to textiles, from cleaning products to contamination control— to empower its distributor...
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Regulatory Affairs Specialist III
4 weeks ago
Richmond, IL, United States Katalyst Healthcares & Life Sciences Full timeRegulatory Affairs Level III (Senior Specialist) Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device). The role includes...
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Regulatory Affairs Manager
1 week ago
Richmond Heights, United States Hospeco Brands Group Full timeCompany OverviewHospeco Brand Groups (Tranzonic Companies) is thehubfor astrategic collectionof manufacturing and salescompaniesthat lead the way in multiple categories — from personal care and protection to textiles, from cleaning products to contamination control— to empowerits distributor partners into the future.Their cohesive approach...
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Richmond, United States Parexel Full timeWe are seeking a motivated Senior / Regulatory Affairs Consultant – Advertising & Promotion to join Parexel and work as a trusted partner within a major client engagement. In this role, you will partner with cross‑functional teams to ensure that all promotional, marketing, educational, and social media materials comply with US regulatory requirements....
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Richmond Heights, United States The Tranzonic Companies Full timeA leading manufacturing company is seeking a Regulatory Affairs Manager to oversee regulatory activities and ensure compliance with various regulatory bodies. The ideal candidate will have over 5 years of experience in regulatory affairs within the chemical industry and a strong understanding of FDA, EPA, and other regulations. Responsibilities include...
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Richmond Heights, United States The Tranzonic Companies Full timeA leading manufacturing company is seeking a Regulatory Affairs Manager to oversee regulatory activities and ensure compliance with various regulatory bodies. The ideal candidate will have over 5 years of experience in regulatory affairs within the chemical industry and a strong understanding of FDA, EPA, and other regulations. Responsibilities include...
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Regulatory Affairs Manager
1 day ago
Richmond, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: Prepare and submit new global market device applications and amendments. Prepare and oversee the review of Traditional (k) Premarket Notifications. Develop and implement regulatory filing timelines for new and existing products in key markets such as US, EU, and Asia markets. Interact with regulatory agency reviewers as well as distribution...
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Regulatory Affairs Specialist III
1 day ago
Richmond, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device) The role includes obtaining and maintaining regulatory approvals,...
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Richmond, United States Kymanox Full time(Contract) Manager, Quality and Regulatory Affairs Join to apply for the (Contract) Manager, Quality and Regulatory Affairs role at Kymanox. You want to make a difference and have an impact. You enjoy having an influence in your day?to?day work. You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow....
