Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and ...
Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and ...
Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies. * RA support in interactions with Health ...
Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies. * RA support in interactions with Health ...
Senior Manager, Drug Product
$122K - $174K/yr
You will contribute to completion (author/review) of relevant drug product sections of regulatory submission documents (IND, IMPD, NDA, briefing packages etc.), responses to regulatory questions and ...
Senior Manager, Drug Product
$122K - $174K/yr
You will contribute to completion (author/review) of relevant drug product sections of regulatory submission documents (IND, IMPD, NDA, briefing packages etc.), responses to regulatory questions and ...
Knowledge of global CMC regulatory submission requirements including submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES). Department lead on the clinical and commercial CMC submission ...
Knowledge of global CMC regulatory submission requirements including submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES). Department lead on the clinical and commercial CMC submission ...
CMC Writer
Paramus, NJ · On-site
Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions * Ensure completion ...
Quick apply
CMC Writer
Paramus, NJ · On-site
Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions * Ensure completion ...
Senior Manager, CMC Global Regulatory Affairs
Medical
Dental
Vision
Life
Retirement
PTO
Plan, prepare, and review CMC sections of regulatory submissions (IMPD/IND/ /MAA/NDA, post-approval variations). Determine regulatory CMC content and scientific/technical requirements to ensure ...
Senior Manager, CMC Global Regulatory Affairs
Medical
Dental
Vision
Life
Retirement
PTO
Plan, prepare, and review CMC sections of regulatory submissions (IMPD/IND/ /MAA/NDA, post-approval variations). Determine regulatory CMC content and scientific/technical requirements to ensure ...
Contribute significant strategic direction and authorship of regulatory documents including clinical IND/IMPD and commercial BLA/MAA * Assess and manage process risks arising from manufacturing or ...
Contribute significant strategic direction and authorship of regulatory documents including clinical IND/IMPD and commercial BLA/MAA * Assess and manage process risks arising from manufacturing or ...
Scientist, Biologics CMC Analytical Development
$146K - $189K/yr
Medical
Dental
Vision
Life
PTO
Contribute to Regulatory and Scientific Deliverables Present findings to senior leadership, author technicalreportsand manuscripts, and support regulatory submissions ( e.g., IND/IMPD/CTA) and ...
Scientist, Biologics CMC Analytical Development
$146K - $189K/yr
Medical
Dental
Vision
Life
PTO
Contribute to Regulatory and Scientific Deliverables Present findings to senior leadership, author technicalreportsand manuscripts, and support regulatory submissions ( e.g., IND/IMPD/CTA) and ...
Director, Biologics Development
Waltham, MA · On-site
$190 - $230/hr
The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite ...
Director, Biologics Development
Waltham, MA · On-site
$190 - $230/hr
The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite ...
Senior Manager / Associate Director, Process Development
South San Francisco, CA · On-site
$160 - $200/hr
Medical
Dental
Vision
Life
Retirement
PTO
Support CMC regulatory submissions by reviewing or contributing to relevant IND/IMPD Module 3 sections. * Work closely with Quality Assurance and Regulatory Affairs to ensure CMC documentation, batch ...
Senior Manager / Associate Director, Process Development
South San Francisco, CA · On-site
$160 - $200/hr
Medical
Dental
Vision
Life
Retirement
PTO
Support CMC regulatory submissions by reviewing or contributing to relevant IND/IMPD Module 3 sections. * Work closely with Quality Assurance and Regulatory Affairs to ensure CMC documentation, batch ...
The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite ...
The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite ...
The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite ...
The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite ...
Experience in CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM). * Solid knowledge of US and international GMP quality regulations, current industry practices, and ...
Experience in CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM). * Solid knowledge of US and international GMP quality regulations, current industry practices, and ...
Program Manager, CRDMO
$140K - $200K/yr
Experience supporting IP, IND, BLA, MAA, or IMPD submissions. * Demonstrated experience leading programs in an IPD, alliance management, or co-development model; CRDMO/sponsor partnership experience ...
Program Manager, CRDMO
$140K - $200K/yr
Experience supporting IP, IND, BLA, MAA, or IMPD submissions. * Demonstrated experience leading programs in an IPD, alliance management, or co-development model; CRDMO/sponsor partnership experience ...
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications * BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent ...
Quick apply
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications * BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent ...
Senior Director/ Director, CMC Regulatory Affairs
South San Francisco, CA · On-site
$250K - $300K/yr
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications * BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent ...
Senior Director/ Director, CMC Regulatory Affairs
South San Francisco, CA · On-site
$250K - $300K/yr
Provide hands-on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications * BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent ...
Contribute to regulatory filings (e.g., IND / IMPD / CTN, NDA) * Identify issues and propose solutions. Proactively assess potential risks to the clinical study and propose mitigation plans * Work in ...
Contribute to regulatory filings (e.g., IND / IMPD / CTN, NDA) * Identify issues and propose solutions. Proactively assess potential risks to the clinical study and propose mitigation plans * Work in ...
Head of Chemistry, Manufacturing, and Controls (CMC)
Boston, MA · On-site
$150 - $200/hr
Oversee IND, CTA, BLA, NDA, MAA, and IMPD CMC documentation * Represent CMC in health authority interactions Vendor Management * Manage external partners, including external auditing and consulting ...
Head of Chemistry, Manufacturing, and Controls (CMC)
Boston, MA · On-site
$150 - $200/hr
Oversee IND, CTA, BLA, NDA, MAA, and IMPD CMC documentation * Represent CMC in health authority interactions Vendor Management * Manage external partners, including external auditing and consulting ...
Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies. * RA support in interactions with Health ...
Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies. * RA support in interactions with Health ...
Senior Manager, Drug Product
Cambridge, MA · On-site
$122K - $174K/yr
You will contribute to completion (author/review) of relevant drug product sections of regulatory submission documents (IND, IMPD, NDA, briefing packages etc.), responses to regulatory questions and ...
Senior Manager, Drug Product
Cambridge, MA · On-site
$122K - $174K/yr
You will contribute to completion (author/review) of relevant drug product sections of regulatory submission documents (IND, IMPD, NDA, briefing packages etc.), responses to regulatory questions and ...
Impd information
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What is the difference between Impd vs Data Analyst?
| Aspect | Impd | Data Analyst |
|---|---|---|
| Required Credentials | Typically requires a degree in engineering, manufacturing, or related fields; certifications like Six Sigma or Lean are common | Requires a degree in statistics, mathematics, or computer science; certifications like CAP or Microsoft Data Analyst are beneficial |
| Work Environment | Primarily in manufacturing or industrial settings, focusing on process improvement and quality control | Mostly in office settings, analyzing data, creating reports, and supporting decision-making |
| Employer & Industry Usage | Used in manufacturing, production, and industrial sectors for process optimization | Used across various industries including finance, healthcare, marketing, and technology for data analysis |
While Impd professionals focus on process improvement within manufacturing environments, Data Analysts interpret data to support business decisions across multiple industries. Both roles require analytical skills but differ in their specific applications and work settings.
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Full-time
Re-posted 28 days ago
Job description
The Opportunity:
As part of our expanding organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC regulatory strategies to support clinical development, marketing authorizations, and lifecycle management of RevMed's pipeline compounds/products.
This role involves coordinating and preparing CMC sections of regulatory submissions to support RevMed's global clinical trials, market applications and post approval changes. The ideal candidate should have a strong understanding of global regulatory requirements during different phases of development, and be able to provide regulatory guidance to the CMC teams accordingly.
Responsibilities:
Develop, lead, and implement global CMC regulatory strategies to support the clinical development, registration, and post-marketing activities.
Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.
Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the development of the investigational product(s) and marketed products and ensure applicable regulatory requirements are appropriately met.
Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify regional/country-specific CMC requirements to support global applications, and to drive the CMC submission timelines in order to meet business objectives.
Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.
Lead and/or contribute to internal process improvements, SOP development, and organizational initiatives to support globalization of RevMed's products.
Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders.
Required Skills, Experience and Education:
BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
10+ years of pharmaceutical / biotech drug development experience with 5 + years of experience of global CMC regulatory affairs.
Experience in CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM).
Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
Working experience and content knowledge in CMC development of NCEs (small molecules) or equivalent.
Demonstrated experience in effective collaboration with internal and external stakeholders.
Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment.
Ability to operate effectively in a fast-paced, matrixed, global environment.
Effective written and verbal communication skills and excellent interpersonal skills.
Preferred Skills:
Advanced degree (MSc or PhD degree) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.
Experience in accelerated development program.
Self-driven, proactive, and able to operate independently while fostering collaboration across departments. #LI-Hybrid #LI-CT1