Regulatory Affairs Jobs in Waltham (MA)
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Search Results - Regulatory Affairs Jobs in Waltham (MA)
Lifelancer-Waltham (MA)
Job Title: Manager, Regulatory Affairs
Job Location: United States
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
About Apogee Therapeutics
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE...
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Ventus Therapeutics-Waltham (MA)
at a fast pace. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.
Position overview:
The Director of Regulatory Affairs...
mindmatch.ai -
Lifelancer-Waltham (MA)
or scientific studies
Experience in project management respectively change control process
Experience in regulatory affairs or in a quality environment, ideally in a pharmaceutical/medical environment of advantage
Knowledgeable in relevant regulations...
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Cedent Consulting Inc-Waltham (MA)
as a subject matter expert.
• Attend and contribute to Safety and Product Safety Committee meetings, presenting safety issues and risk mitigation strategies.
• Collaborate with Regulatory Affairs and cross-functional teams on safety concerns, benefit-risk...
appcast.io -
Deciphera Pharmaceuticals-Waltham (MA)
detection, and ad hoc as needed
Attend/lead Safety committee 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...
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Sionna Therapeutics-Waltham (MA)
on program team as the commercial lead and work closely with Clinical Development, Medical Affairs, Regulatory Affairs, and other cross-functional teams to align commercial strategy with clinical, scientific, and regulatory approaches.
• Identify key clinical...
mindmatch.ai -
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...
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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...
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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...
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Lifelancer-Waltham (MA)
the study design, execution and interpretation of results, with a focus on proof-of-concept and later phases of development.
Cross-functional Collaboration: Work closely with cross-functional teams including Biostatistics, Regulatory Affairs...
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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...
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Mindlance-Waltham (MA)
Products produced by plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands.
Grade is commensurate on level...
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