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Review CMC sections of IND/CTA, NDA/BLA/MAA, and other global submissions in support of clinical development, marketing applications, commercial product, and their amendments/supplements/variations in conformance with local regulatory requirements.
$234,900 - $290,200 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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As a Regulatory Affairs Manager II , you will be responsible for the strategic leadership, management, and oversight of Regulatory Affairs teams at QSD to meet business and customer needs throughout the product lifecycle while assuring compliance with domestic and international regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Work closely with Research and Development, Medical Affairs, Quality Engineering, Product Management, Labeling, as well as global Regulatory Affairs affiliates.
$90,000 - $130,000 a yearExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
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Demonstrated successful leadership experience, including developing/mentoring/coaching others and collaborating in multi-functional teams including Global Sales & Marketing (GSM), Regulatory, Legal, Clinical/Medical Affairs, Quality, Corporate Communications, and other Functional Departments.
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Partner with Regulatory Affairs, Human Factors Engineering, Marketing, and Clinical Affairs to ensure accurate representation of BAYER products to the end user through product labeling.
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Lead development and execution of global product and project regulatory, strategy(ies) for assigned Veterinary products in accordance with global regulations and guidance. Hands on experience on authoring CMC documentation for worldwide marketing of Veterinary products for initial registration and life-cycle management.
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Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment reports and Expert reports.
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The regulatory strategy addresses the Target Product Profile, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies as well as life product cycle management strategy.
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PFG focuses on discovering, developing, and marketing nature-derived biostimulants, as well as pest management products from microbes and plant extracts for the effective control of invertebrate pests, weeds, and plant diseases.
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