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.



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