EPM Scientific
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Direct message the job poster from EPM Scientific
Base pay range $130,000.00/yr - $170,000.00/yr
Regulatory Affairs – Principal Recruitment Consultant Title:
Senior Manager Regulatory CMC
The
Senior Manager, Regulatory Affairs - CMC
will play a key role within the Regulatory Affairs team, focusing on Chemistry, Manufacturing, and Controls (CMC) for drug-device combination products. This individual will lead regulatory strategy and documentation efforts, support cross‑functional teams on product and process changes, and ensure compliance with global regulatory requirements. Responsibilities include managing submissions for new products and post‑approval changes, overseeing periodic reporting obligations, and providing strategic guidance to project teams.
Responsibilities
Develop and execute CMC regulatory strategies for combination products, including authoring and reviewing submissions (INDs, NDAs, DMFs, etc.) and related documentation (specifications, development reports, protocols, NCRs, CAPAs).
Support creation and maintenance of labeling for new and marketed products, including prescribing information, instructions for use, and packaging components.
Lead or participate in CMC‑related change control processes; assess regulatory impact of post‑approval changes and prepare required submissions.
Manage preparation and submission of periodic reports to regulatory authorities.
Collaborate with Quality and Regulatory leadership on field actions, recalls, and associated communications when necessary.
Identify and implement process improvements to enhance efficiency and maintain compliance with evolving regulations.
Qualifications
Bachelor's degree in a scientific discipline (Chemistry, Chemical Engineering, Pharmaceutical Sciences, etc.) with 7–10 years of experience in product development, manufacturing, CMC, Regulatory, or Quality. Advanced degree and/or cross‑functional experience preferred.
Strong knowledge of CMC regulatory requirements, FDA guidance, and global standards; experience with drug‑device combination products is a plus.
Proven experience preparing and reviewing regulatory submissions (INDs/CTAs, NDAs/MAAs, etc.).
Familiarity with post‑approval change assessments and GMP/GDP principles.
Proficiency in project management tools and techniques for cross‑functional deliverables.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Other
Industries
Plastics Manufacturing
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Direct message the job poster from EPM Scientific
Base pay range $130,000.00/yr - $170,000.00/yr
Regulatory Affairs – Principal Recruitment Consultant Title:
Senior Manager Regulatory CMC
The
Senior Manager, Regulatory Affairs - CMC
will play a key role within the Regulatory Affairs team, focusing on Chemistry, Manufacturing, and Controls (CMC) for drug-device combination products. This individual will lead regulatory strategy and documentation efforts, support cross‑functional teams on product and process changes, and ensure compliance with global regulatory requirements. Responsibilities include managing submissions for new products and post‑approval changes, overseeing periodic reporting obligations, and providing strategic guidance to project teams.
Responsibilities
Develop and execute CMC regulatory strategies for combination products, including authoring and reviewing submissions (INDs, NDAs, DMFs, etc.) and related documentation (specifications, development reports, protocols, NCRs, CAPAs).
Support creation and maintenance of labeling for new and marketed products, including prescribing information, instructions for use, and packaging components.
Lead or participate in CMC‑related change control processes; assess regulatory impact of post‑approval changes and prepare required submissions.
Manage preparation and submission of periodic reports to regulatory authorities.
Collaborate with Quality and Regulatory leadership on field actions, recalls, and associated communications when necessary.
Identify and implement process improvements to enhance efficiency and maintain compliance with evolving regulations.
Qualifications
Bachelor's degree in a scientific discipline (Chemistry, Chemical Engineering, Pharmaceutical Sciences, etc.) with 7–10 years of experience in product development, manufacturing, CMC, Regulatory, or Quality. Advanced degree and/or cross‑functional experience preferred.
Strong knowledge of CMC regulatory requirements, FDA guidance, and global standards; experience with drug‑device combination products is a plus.
Proven experience preparing and reviewing regulatory submissions (INDs/CTAs, NDAs/MAAs, etc.).
Familiarity with post‑approval change assessments and GMP/GDP principles.
Proficiency in project management tools and techniques for cross‑functional deliverables.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Other
Industries
Plastics Manufacturing
#J-18808-Ljbffr