Regulatory Affairs Specialist
hace 1 semana
We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Pharmaceutical Research Associates, Inc. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with Cofepris regulations for drug promotion/advertising and labeling.
The successful candidate will have excellent understanding of Cofepris regulations and experience interacting with the agency. Proficiency in Veeva Vault PromoMats or similar document management systems is an added advantage.
About the Role- Demonstrated expertise in regulatory requirements for labeling and advertising materials.
- Experience in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance.
- Knowledge of Common Technical Document and global guidelines on content and format of labeling preferred.
- Experience with creating and reviewing labeling and advertising materials required.
- Manage multiple tasks and multifunctional resources concurrently, responding to rapidly changing priorities and aggressive deadlines.
- Communicate effectively with all levels of personnel, both locally and globally.
- Work independently with flexibility, connecting and collaborating with clients and team members remotely.
- Provide strategic direction and innovative regulatory guidance, analyzing and interpreting efficacy and safety data.
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Ciudad de México, Ciudad de México Amgen SA A tiempo completoTransform the lives of patients by ensuring timely and compliant regulatory submissions for Amgen SA. As a Senior Associate Regulatory Affairs professional, you will play a pivotal role in maintaining the company's reputation for quality and innovation.In this exciting opportunity, you will be responsible for preparing, reviewing, and approving source text...
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Regulatory Affairs Specialist
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Ciudad de México, Ciudad de México Select Assistants A tiempo completoAbout Select Assistants">Select Assistants is a leading provider of premium medical skincare products, renowned for delivering science-backed solutions to the industry. We are committed to shaping the future of skincare by leveraging innovation and regulatory excellence.">The Role: Regulatory Compliance & FDA Oversight">">Manage product registrations and...
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Ciudad de México, Ciudad de México Icon A tiempo completoCompany Overview:At ICON, our mission is to advance and improve patients' lives by providing exceptional clinical research services.We pride ourselves on being a diverse team of talented individuals who work together to deliver excellence to our clients and patients at every touch-point.We're driven by our core values: Accountability & Delivery,...
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Ciudad de México, Ciudad de México Indorama Ventures: Indovinya A tiempo completoJob Overview: As a Regulatory Affairs Specialist at Indorama Ventures: Indovinya, you will play a critical role in ensuring compliance with international and local regulations surrounding controlled substances. This includes expertise in regulatory requirements, data analysis, and collaboration with cross-functional teams to support the organization's global...
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Regulatory Affairs Director
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