Global Regulatory Affairs Specialist in Framingham, MA US at Apex Systems

Company: Apex Systems Inc.
Location: Framingham
Posted on: April 6, 2021

Job Description:

Global Regulatory Affairs Specialist in Framingham, MA US at Apex Systems 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 current 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 are in compliance with regulatory licenses (in all applicable countries). Qualifications

• In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing.
• Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to drug and/or biologic regulations.
• Have direct hands-on experience with post-marketing regulatory activities (i.e. AR, CBE-30, PAS, Variations) for biologic and/or drug products Education:
  • 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 EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178. Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com (Do not submit resumes or solicit consultants to this email address) or 844-463-6178. Join our Talent Network!

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