CMC Regulatory Affairs Specialist
Katalyst Healthcares & Life Sciences
Manhattan, NY, NY
cmc
cmc regulatory affairs
regulatory
regulatory
manufacturing
communication
cmc
team
technical
qa
communication skills
regulations
director
November 24, 2022
Katalyst Healthcares & Life Sciences
Manhattan, NY, NY
FULL_TIME
Roles and Responsibilities:
Reporting to the Director, Global Regulatory CMC, this position will provide Regulatory CMC support for Biologics.
Interacts with RA colleagues world-wide; Coordinates and prepares regulatory document packages to support pre- and post-market changes; Provides project team representation, consults on regulatory project needs and is responsible for coordinating and reviewing required regulatory documentation/submissions. Provides direction in managing information from/to other departments.
Monitors and tracks information, ensuring accurate communication of the status of post-approval change control assessments and submissions.
Reviews technical documentation; Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals; Responsible for determining if changes and deviations follow regulatory licenses (in all applicable countries).
Education and Experience:
Bachelors or master's degree in the Life Sciences or Engineering and at least 3 years of relevant experience in regulatory, manufacturing, technical development or QA/QC, or related fields
In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing.
Excellent written and verbal communication skills.
Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to drug and/or biologic regulations.
Strong understanding of manufacturing processes
Excellent organizational skills demonstrated ability to prioritize multiple projects.
Ability to work in a team environment, possessing interpersonal skills to effectively work with other departments at various levels. Excellent communication skills and ability to influence across the broadest of constituencies.
Have direct hands-on experience with post-marketing regulatory activities (i.e., AR, CBE-30, Client, Variations) for biologic and/or drug products
Ability to effectively interpret guidance and provide recommendation to key stakeholders.
Regulatory, Manufacturing, QA/QC experience
Proficient in MS Word, Excel, PowerPoint, MS Project.
Ability to set ambitious and realistic targets, drive for results and build accountability.
Ability to effectively manage the balance between delegation/empowerment and a hands-on approach.
Reporting to the Director, Global Regulatory CMC, this position will provide Regulatory CMC support for Biologics.
Interacts with RA colleagues world-wide; Coordinates and prepares regulatory document packages to support pre- and post-market changes; Provides project team representation, consults on regulatory project needs and is responsible for coordinating and reviewing required regulatory documentation/submissions. Provides direction in managing information from/to other departments.
Monitors and tracks information, ensuring accurate communication of the status of post-approval change control assessments and submissions.
Reviews technical documentation; Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals; Responsible for determining if changes and deviations follow regulatory licenses (in all applicable countries).
Education and Experience:
Bachelors or master's degree in the Life Sciences or Engineering and at least 3 years of relevant experience in regulatory, manufacturing, technical development or QA/QC, or related fields
In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing.
Excellent written and verbal communication skills.
Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to drug and/or biologic regulations.
Strong understanding of manufacturing processes
Excellent organizational skills demonstrated ability to prioritize multiple projects.
Ability to work in a team environment, possessing interpersonal skills to effectively work with other departments at various levels. Excellent communication skills and ability to influence across the broadest of constituencies.
Have direct hands-on experience with post-marketing regulatory activities (i.e., AR, CBE-30, Client, Variations) for biologic and/or drug products
Ability to effectively interpret guidance and provide recommendation to key stakeholders.
Regulatory, Manufacturing, QA/QC experience
Proficient in MS Word, Excel, PowerPoint, MS Project.
Ability to set ambitious and realistic targets, drive for results and build accountability.
Ability to effectively manage the balance between delegation/empowerment and a hands-on approach.
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