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Remote CMC Manager, Regulatory Affairs

Jobgether
Full-time
On-site
remote
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Remote CMC Manager, Regulatory Affairs. In this role, you will play a crucial part in navigating the complex landscape of regulatory submissions. Your expertise will help ensure that products comply with health regulations, paving the way for approvals that impact both human and animal health. You will engage with project teams to drive forward critical initiatives, all while maintaining high standards during the regulatory process. This position requires effective communication and project management to liaise with stakeholders effectively. Join us to make a meaningful impact on health outcomes globally.

Accountabilities

  • Co-ordinate and compile regulatory submissions and agency correspondence for assigned projects
  • Implement action plans to achieve timely approval of submissions ensuring compliance
  • Participate in and support project teams to achieve regulatory goals
  • Prioritize, coordinate, and complete multiple projects within established timeframes
  • Identify client and dossier issues, developing effective strategies to resolve them
  • Build and maintain positive relations with internal and external contacts
  • Proactive project management to ensure project alignment with budget and timelines
  • Oversee quality control of documents and data as needed
  • Expand professional regulatory knowledge to offer effective consulting services

    • Requirements

  • B.Sc. in Life Sciences or equivalent experience; advanced degree preferred
  • Certification in Regulatory Affairs (RAC) is a plus
  • 5 - 8 years experience in Regulatory Affairs or relevant industry experience
  • Direct experience with health care products including Biologics and Therapeutics
  • Strong knowledge of local Health Authority regulations and guidelines
  • Excellent time management and organizational skills
  • Effective project management and problem-solving abilities
  • Proficiency with MS Office, Adobe Professional, and Veeva Vault

    • Benefits

  • Comprehensive medical, dental, and vision care
  • Support for working families including backup care and adoption assistance
  • Behavioral health solutions and paid parental leave
  • Mentorship programs and professional development resources
  • Flexible working arrangements to promote work-life balance

    • Why Apply Through Jobgether?
    We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
    We appreciate your interest and wish you the best!
    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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