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Regulatory Affairs Jobs in Waltham (MA)

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Search Results - Regulatory Affairs Jobs in Waltham (MA)
Lifelancer-Waltham (MA)
Job Title: Mgr, Regulatory Affairs Pharma - HealthCanada Job Location: Waltham, MA, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level PURPOSE AND SCOPE: Ensure overall (other than auditing...
resume-library.com -
HireMinds-Waltham (MA)
but are not limited to:  •  Evolve Quality Systems parameters to meet requirements of various drug and device development stages.  •  Partner with GXP Operations to assist in oversight of contract service providers.  •  Assist Regulatory Affairs in the preparation...
mindmatch.ai -
Katalyst Healthcares & Life Sciences-Waltham (MA)
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...
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GlaxoSmithKline-Waltham (MA)
of the drug development process in regulatory affairs preferred.  •  Experience with clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.  •  Experience in relevant therapy...
appcast.io -
AbbVie-Waltham (MA)
Job Description As an Associate Director of Regulatory Affairs in Chemistry, Manufacturing, and Controls (CMC), you will collaborate with both internal and external partners to ensure the successful delivery of products to patients. Your scope...
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Apellis Pharmaceuticals, Inc.-Waltham (MA)
participate in design and validation activities for the implementation of RIMS, including electronic Regulatory Document Management System (EDM). Requires a Masters degree in Biotechnology, Biology, Drug Regulatory Affairs, or a related field and 2 years...
jobvertise.com -
Katalyst Healthcares & Life Sciences-Waltham (MA)
drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. This role will build and maintain relationships with scientific staff, lab champions, functional...
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Deciphera Pharmaceuticals, Inc.-Waltham (MA)
meeting to support key decision-making, drive conclusions and develop next steps.  •  Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit-risk assessments.  •  Participate...
appcast.io -
Lifelancer-Waltham (MA)
required quality standards are maintained Liaise with Regulatory Affairs on any manufacturing process changes that may impact regulatory filings Collaborate with CMC to continually improve compliance with quality systems, internal SOPs, and regulatory...
resume-library.com -
Lifelancer-Waltham (MA)
Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND filing, and clinical development of biologics. Provide leadership and management support that can...
resume-library.com -

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