Biological Product Development * Technical Development * Trend Monitoring Soft Skills * Strong Communication Skills * Negotiation Skills * Influencing Skills Industry Keywords * Pharmaceutical ...
Biological Product Development * Technical Development * Trend Monitoring Soft Skills * Strong Communication Skills * Negotiation Skills * Influencing Skills Industry Keywords * Pharmaceutical ...
Director of Regulatory - Biological & Traditional Fertilizers
Durham, NC ยท On-site
$144K - $191K/yr
This role serves as a strategic advisor to R&D, product development, quality, legal, and commercial ... monitor evolving regulatory frameworks and adapt strategies accordingly.Contribute to the building ...
Director of Regulatory - Biological & Traditional Fertilizers
Durham, NC ยท On-site
$144K - $191K/yr
This role serves as a strategic advisor to R&D, product development, quality, legal, and commercial ... monitor evolving regulatory frameworks and adapt strategies accordingly.Contribute to the building ...
Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals. * Monitor and assess regulatory guidance related to ...
Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals. * Monitor and assess regulatory guidance related to ...
Staff Scientist/Senior Manager, Biology
San Diego, CA ยท On-site
$130K - $150K/yr
Monitor scientific, technical, regulatory, and industry trends to identify strategic opportunities ... and biological product development. * Experience with product development, technology transfer ...
New
Staff Scientist/Senior Manager, Biology
San Diego, CA ยท On-site
$130K - $150K/yr
Monitor scientific, technical, regulatory, and industry trends to identify strategic opportunities ... and biological product development. * Experience with product development, technology transfer ...
New
Head of Global Product Quality- Biologics
Cambridge, MA ยท Hybrid
$184K - $253K/yr
Ensure timely completion of Annual Product Review/Product Quality Review and trend monitoring ... biological product development and/or production. * At least 7 years of experience in Quality ...
Head of Global Product Quality- Biologics
Cambridge, MA ยท Hybrid
$184K - $253K/yr
Ensure timely completion of Annual Product Review/Product Quality Review and trend monitoring ... biological product development and/or production. * At least 7 years of experience in Quality ...
Head of Global Product Quality- Biologics
Cambridge, MA ยท On-site
$184K - $253K/yr
Ensure timely completion of Annual Product Review/Product Quality Review and trend monitoring ... biological product development and/or production. * At least 7 years of experience in Quality ...
Head of Global Product Quality- Biologics
Cambridge, MA ยท On-site
$184K - $253K/yr
Ensure timely completion of Annual Product Review/Product Quality Review and trend monitoring ... biological product development and/or production. * At least 7 years of experience in Quality ...
Biologist
Manassas, VA ยท On-site
$65K - $75K/yr
Production Operations: Conduct manufacturing processes for biological materials, including ... Maintain inventory, monitor equipment functionality, and support laboratory readiness in BSL-1 and ...
Biologist
Manassas, VA ยท On-site
$65K - $75K/yr
Production Operations: Conduct manufacturing processes for biological materials, including ... Maintain inventory, monitor equipment functionality, and support laboratory readiness in BSL-1 and ...
Epidemiologist
Washington, DC ยท On-site
... biological products. The contractor supports regulatory review activities by assisting in the ... monitor progress, and ensure timely completion of deliverables. โข Ensure all work products comply ...
Epidemiologist
Washington, DC ยท On-site
... biological products. The contractor supports regulatory review activities by assisting in the ... monitor progress, and ensure timely completion of deliverables. โข Ensure all work products comply ...
Biologist
Manassas, VA ยท On-site
$65K - $75K/yr
Production Operations: Conduct manufacturing processes for biological materials, including ... Maintain inventory, monitor equipment functionality, and support laboratory readiness in BSL-1 and ...
Biologist
Manassas, VA ยท On-site
$65K - $75K/yr
Production Operations: Conduct manufacturing processes for biological materials, including ... Maintain inventory, monitor equipment functionality, and support laboratory readiness in BSL-1 and ...
Biologist
Manassas, VA ยท On-site
$65K - $75K/yr
Production Operations: Conduct manufacturing processes for biological materials, including ... Maintain inventory, monitor equipment functionality, and support laboratory readiness in BSL-1 and ...
Biologist
Manassas, VA ยท On-site
$65K - $75K/yr
Production Operations: Conduct manufacturing processes for biological materials, including ... Maintain inventory, monitor equipment functionality, and support laboratory readiness in BSL-1 and ...
Epidemiologist
Washington, DC ยท Remote
... biological products. The contractor supports regulatory review activities by assisting in the ... monitor progress, and ensure timely completion of deliverables. ยท Ensure all work products comply ...
Quick apply
Epidemiologist
Washington, DC ยท Remote
... biological products. The contractor supports regulatory review activities by assisting in the ... monitor progress, and ensure timely completion of deliverables. ยท Ensure all work products comply ...
Biological Technician
Mammoth, WY ยท On-site
$24.41/hr
Our educational programming and products help people enhance their understanding and appreciation ... monitoring, photographic, and laboratory equipment). Inventories equipment, evaluates quality ...
Biological Technician
Mammoth, WY ยท On-site
$24.41/hr
Our educational programming and products help people enhance their understanding and appreciation ... monitoring, photographic, and laboratory equipment). Inventories equipment, evaluates quality ...
Epidemiologist
Washington, DC ยท On-site +1
... biological products. The contractor supports regulatory review activities by assisting in the ... monitor progress, and ensure timely completion of deliverables. ยท Ensure all work products comply ...
Epidemiologist
Washington, DC ยท On-site +1
... biological products. The contractor supports regulatory review activities by assisting in the ... monitor progress, and ensure timely completion of deliverables. ยท Ensure all work products comply ...
Product Manager
Gaithersburg, MD ยท On-site
$115K - $130K/yr
A global nonprofit that provides trusted biological materials for science and health, ATCC is ... Monitor portfolio performance and recommend actions to maximize growth. Identify opportunities to ...
Product Manager
Gaithersburg, MD ยท On-site
$115K - $130K/yr
A global nonprofit that provides trusted biological materials for science and health, ATCC is ... Monitor portfolio performance and recommend actions to maximize growth. Identify opportunities to ...
Staff Scientist/Senior Manager, Biology
San Diego, CA ยท On-site
$130K - $150K/yr
Monitor scientific, technical, regulatory, and industry trends to identify strategic opportunities ... and biological product development. * Experience with product development, technology transfer ...
New
Staff Scientist/Senior Manager, Biology
San Diego, CA ยท On-site
$130K - $150K/yr
Monitor scientific, technical, regulatory, and industry trends to identify strategic opportunities ... and biological product development. * Experience with product development, technology transfer ...
New
Staff Scientist/Senior Manager, Biology
$130K - $150K/yr
Monitor scientific, technical, regulatory, and industry trends to identify strategic opportunities ... and biological product development. * Experience with product development, technology transfer ...
New
Quick apply
Staff Scientist/Senior Manager, Biology
$130K - $150K/yr
Monitor scientific, technical, regulatory, and industry trends to identify strategic opportunities ... and biological product development. * Experience with product development, technology transfer ...
New
Staff Scientist/Senior Manager, Biology
San Diego, CA ยท On-site
$130K - $150K/yr
Monitor scientific, technical, regulatory, and industry trends to identify strategic opportunities ... and biological product development. * Experience with product development, technology transfer ...
New
Quick apply
Staff Scientist/Senior Manager, Biology
San Diego, CA ยท On-site
$130K - $150K/yr
Monitor scientific, technical, regulatory, and industry trends to identify strategic opportunities ... and biological product development. * Experience with product development, technology transfer ...
New
Product Manager
Gaithersburg, MD ยท On-site +1
$115K - $130K/yr
A global nonprofit that provides trusted biological materials for science and health, ATCC is ... Monitor portfolio performance and recommend actions to maximize growth. Identify opportunities to ...
Product Manager
Gaithersburg, MD ยท On-site +1
$115K - $130K/yr
A global nonprofit that provides trusted biological materials for science and health, ATCC is ... Monitor portfolio performance and recommend actions to maximize growth. Identify opportunities to ...
Product Manager
Gaithersburg, MD ยท On-site +1
$115K - $130K/yr
A global nonprofit that provides trusted biological materials for science and health, ATCC is ... Monitor portfolio performance and recommend actions to maximize growth. Identify opportunities to ...
Product Manager
Gaithersburg, MD ยท On-site +1
$115K - $130K/yr
A global nonprofit that provides trusted biological materials for science and health, ATCC is ... Monitor portfolio performance and recommend actions to maximize growth. Identify opportunities to ...
CMC Statistician (Berkeley, California, US)
Berkeley, CA ยท On-site
$165K - $185K/yr
Monitoring biological systems & making recommendations regarding process control and optimization ... Supporting biological processes, product development & GMP cell therapy manufacturing applying ...
CMC Statistician (Berkeley, California, US)
Berkeley, CA ยท On-site
$165K - $185K/yr
Monitoring biological systems & making recommendations regarding process control and optimization ... Supporting biological processes, product development & GMP cell therapy manufacturing applying ...
Biological Product Monitor information
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For Biological Product Monitor jobs, the most frequently searched job titles are:

Head of Global Product Quality - Biologics
Cambridge, MA โข On-site
Other
Re-posted 9 days ago
Job description
- Lead asset strategy and compliance best practices across products within a modality.
- Review major regulatory submissions and help set up regulatory strategic plans.
- Develop and cross-train staff for maximum flexibility and growth.
- Execute specification strategy for regulatory submissions and address agency concerns.
- Collaborate with cross-functional teams to support product specifications and shelf-life strategy.
- Serve as the Specification Review Board Chair and ensure cross-functional vetting of specifications.
- Represent Biogen at external forums to stay abreast of emerging expectations and trends.
- Ensure timely completion of Annual Product Review/Product Quality Review and trend monitoring.
- Support internal audits, certifications, and external audits of CMOs.
- Support combination product and device implementations in asset strategy.
Requirements
- Bachelorโs degree and at least 12 years of experience in the pharmaceutical industry, with biological product development and/or production.
- At least 7 years of experience in Quality associated with biopharmaceutical/pharmaceutical production.
- Minimum of 5 years of experience in people management and project management.
- Extensive knowledge in GMPs, GCP, GDP, ICH, and international regulations.
- Experience in an international matrix environment.
- Technical expertise in manufacturing, testing, or technical development.
- Strong written and verbal communication skills.
- Ability to influence partners and stakeholders with strong negotiation skills.
Core Competencies
Demonstrates extensive expertise in regulatory strategy and compliance within the pharmaceutical industry, with a strong focus on GMPs, GCP, and international regulations. Proven ability to lead cross-functional teams, manage projects, and influence stakeholders effectively.
Highest-signal resume keywords
- Regulatory Strategy Development
- GMP Knowledge
- Quality Management Experience
- People Management
- Project Management
ATS Optimization Keywords
Hard Skills
- Regulatory Submissions
- Specification Strategy
- Biological Product Development
- Technical Development
- Trend Monitoring
Soft Skills
- Strong Communication Skills
- Negotiation Skills
- Influencing Skills
Industry Keywords
- Pharmaceutical Industry
- Biopharmaceutical Production
- International Regulations
- GCP
- GDP
- ICH