Provide training to junior staff members on CMC-related regulatory requirements and best practices. Profile * Minimum of 3 years of experience in Regulatory Affairs focusing on CMC within the ...
Provide training to junior staff members on CMC-related regulatory requirements and best practices. Profile * Minimum of 3 years of experience in Regulatory Affairs focusing on CMC within the ...
CMC Project Manager
Raleigh, NC · On-site
CMC Project Manager ICON is a global healthcare intelligence and clinical research organisation ... Learning and development opportunities through structured training and career pathways Benefits may ...
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CMC Project Manager
Raleigh, NC · On-site
CMC Project Manager ICON is a global healthcare intelligence and clinical research organisation ... Learning and development opportunities through structured training and career pathways Benefits may ...
CMC Project Manager
Belgium, WI · On-site
CMC Project Manager ICON is a global healthcare intelligence and clinical research organisation ... Learning and development opportunities through structured training and career pathways Benefits may ...
CMC Project Manager
Belgium, WI · On-site
CMC Project Manager ICON is a global healthcare intelligence and clinical research organisation ... Learning and development opportunities through structured training and career pathways Benefits may ...
CMC Statistics Director
Boston, MA · On-site
The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the ... Develop and deliver statistical training programs that increase statistical literacy and data ...
CMC Statistics Director
Boston, MA · On-site
The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the ... Develop and deliver statistical training programs that increase statistical literacy and data ...
CMC Project Manager
Cambridge, MA · On-site
Formal project or program management training/certification is a plus. Location: Boston Candidates with backgrounds in CMC Project Management, CMC Program Management, Technical Operations, MSAT ...
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CMC Project Manager
Cambridge, MA · On-site
Formal project or program management training/certification is a plus. Location: Boston Candidates with backgrounds in CMC Project Management, CMC Program Management, Technical Operations, MSAT ...
Executive Director, Regulatory Affairs, CMC
$153K - $202K/yr
S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based ... Advanced scientific training with hands-on expertise in at least one core pharmaceutical or ...
Executive Director, Regulatory Affairs, CMC
$153K - $202K/yr
S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based ... Advanced scientific training with hands-on expertise in at least one core pharmaceutical or ...
CMC Statistics Director
Boston, MA · On-site
The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the ... Develop and deliver statistical training programs that increase statistical literacy and data ...
CMC Statistics Director
Boston, MA · On-site
The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the ... Develop and deliver statistical training programs that increase statistical literacy and data ...
Director/ Senior Director, Regulatory CMC
Boston, MA · On-site
$250K - $265K/yr
Strong scientific background and training in manufacturing processes and development and ... A broad understanding of all aspects of CMC including process development, regulatory and quality ...
Director/ Senior Director, Regulatory CMC
Boston, MA · On-site
$250K - $265K/yr
Strong scientific background and training in manufacturing processes and development and ... A broad understanding of all aspects of CMC including process development, regulatory and quality ...
... strategies, training requirements, resourcing and budgetary requirements. Engage with key ... CMC/Project Management environment Change management experience Familiarity with global CMC ...
... strategies, training requirements, resourcing and budgetary requirements. Engage with key ... CMC/Project Management environment Change management experience Familiarity with global CMC ...
Champion enterprise AI adoption via networks (e.g., AI Pioneers Champions Network), feedback loops, and change management/training. * Propose/lead/mentor digital project teams, including GRACS CMC ...
Champion enterprise AI adoption via networks (e.g., AI Pioneers Champions Network), feedback loops, and change management/training. * Propose/lead/mentor digital project teams, including GRACS CMC ...
Executive Director, Regulatory Affairs, CMC
$153K - $202K/yr
S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based ... Advanced scientific training with hands-on expertise in at least one core pharmaceutical or ...
Executive Director, Regulatory Affairs, CMC
$153K - $202K/yr
S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based ... Advanced scientific training with hands-on expertise in at least one core pharmaceutical or ...
Associate Director, CMC Regulatory Affairs
Paramus, NJ · On-site
$170K - $190K/yr
CMC Regulatory Affairs develops and executes CMC regulatory strategies for investigational and ... Career Development, Progression and Training * Flexible Work Arrangement Programs * Paid Parental ...
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Associate Director, CMC Regulatory Affairs
Paramus, NJ · On-site
$170K - $190K/yr
CMC Regulatory Affairs develops and executes CMC regulatory strategies for investigational and ... Career Development, Progression and Training * Flexible Work Arrangement Programs * Paid Parental ...
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$180K - $237K/yr
... training and experience. RAC certification is a plus. * Excellent verbal and written communication ... Proven track record of leading CMC regulatory submissions (INDs, NDAs, BLAs) and successful ...
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Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$180K - $237K/yr
... training and experience. RAC certification is a plus. * Excellent verbal and written communication ... Proven track record of leading CMC regulatory submissions (INDs, NDAs, BLAs) and successful ...
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$180K - $237K/yr
... training and experience. RAC certification is a plus. * Excellent verbal and written communication ... Proven track record of leading CMC regulatory submissions (INDs, NDAs, BLAs) and successful ...
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$180K - $237K/yr
... training and experience. RAC certification is a plus. * Excellent verbal and written communication ... Proven track record of leading CMC regulatory submissions (INDs, NDAs, BLAs) and successful ...
Oversees regulatory submissions trackers Supports the monitoring of global CMC process, evaluation of metrics periodically, monitoring the process, supports changes and provides training and tools.
Oversees regulatory submissions trackers Supports the monitoring of global CMC process, evaluation of metrics periodically, monitoring the process, supports changes and provides training and tools.
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$180K - $237K/yr
... training and experience. RAC certification is a plus. * Excellent verbal and written communication ... Proven track record of leading CMC regulatory submissions (INDs, NDAs, BLAs) and successful ...
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$180K - $237K/yr
... training and experience. RAC certification is a plus. * Excellent verbal and written communication ... Proven track record of leading CMC regulatory submissions (INDs, NDAs, BLAs) and successful ...
Assoc. Dir, Regulatory Affairs-CMC
Rahway, NJ · On-site
$150 - $200/hr
... and training activities. * Mentorship & Community Building: Propose, lead, and mentor digital ... GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement--while ...
Assoc. Dir, Regulatory Affairs-CMC
Rahway, NJ · On-site
$150 - $200/hr
... and training activities. * Mentorship & Community Building: Propose, lead, and mentor digital ... GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement--while ...
Senior Manager, CMC Technical Operations
$135K - $165K/yr
Senior Director, CMC Product Champion Location: Remote Work, US only Why Sabin: Our mission is to ... Direct experience and training in current good manufacturing practices (cGMP) * Working knowledge ...
Senior Manager, CMC Technical Operations
$135K - $165K/yr
Senior Director, CMC Product Champion Location: Remote Work, US only Why Sabin: Our mission is to ... Direct experience and training in current good manufacturing practices (cGMP) * Working knowledge ...
... and training activities. * Mentorship & Community Building: Propose, lead, and mentor digital ... GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement-while ...
... and training activities. * Mentorship & Community Building: Propose, lead, and mentor digital ... GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement-while ...
... and training activities. * Mentorship & Community Building: Propose, lead, and mentor digital ... GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement-while ...
... and training activities. * Mentorship & Community Building: Propose, lead, and mentor digital ... GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement-while ...
Cmc Trainer information
See salary details
$11.54 - $14.86
3% of jobs
$14.86 - $18.18
16% of jobs
$19.14 is the 25th percentile. Wages below this are outliers.
$18.18 - $21.50
20% of jobs
The median wage is $23.72 / hr.
$21.50 - $24.83
16% of jobs
$24.83 - $28.15
14% of jobs
$29.81 is the 75th percentile. Wages above this are outliers.
$28.15 - $31.47
12% of jobs
$31.47 - $34.79
9% of jobs
$34.79 - $38.11
3% of jobs
$38.11 - $41.43
4% of jobs
$41.43 - $44.76
2% of jobs
$44.76 - $48.08
1% of jobs
$11
$27
$48
How much do cmc trainer jobs pay per hour?
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Job description
The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory submissions for pharmaceutical products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory requirements throughout the product lifecycle, from development through post-approval.
Main Responsibilities
- Develop and compile high-quality CMC documentation required for regulatory submissions, including INDs, BLAs, NDAs, and variations
- Ensure that all documents meet the necessary regulatory standards and guidelines.
- Prepare necessary documentation for submission to regulatory authorities regarding these changes.
- Work closely with Research & Development (R&D), Quality Assurance (QA), Manufacturing, and other departments to gather technical data and ensure alignment on regulatory strategies.
- Serve as a point of contact for interactions with regulatory agencies. Prepare responses to agency inquiries and facilitate meetings as needed.
- Provide training to junior staff members on CMC-related regulatory requirements and best practices.
Profile
- Minimum of 3 years of experience in Regulatory Affairs focusing on CMC within the pharmaceutical or biopharmaceutical industry.
- Bachelors degree in chemistry, biology, biochemistry.
- Strong understanding of ICH guidelines, FDA regulations, EMA guidelines, and other relevant international regulations
Benefits
- Remote working opportunity
- Competitive salary, bonus and other benefits
- Opportunity for professional development and growth
- Excellent company culture