Talent.com
RIMS Manager

RIMS Manager

Freyr SolutionsCanada
23 hours ago
Job type
  • Permanent
  • Full-time
Job description

About Freyr Life Sciences :

Freyr Life Sciences is the largest global Regulatory Solutions & Services provider, supporting Life Sciences companies of all sizes—pharmaceutical, medical device, and biotech—in navigating the complexities of regulatory compliance. As a fast-growing and innovative company, Freyr offers end-to-end regulatory solutions, including Regulatory Strategy, Intelligence, Dossiers, Submissions, Post-Approval / Legacy Product Maintenance, Labeling, Artwork Change Management, and related functions. With a commitment to excellence and innovation, we enable clients to manage their entire regulatory value chain efficiently.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint to Warsaw, Poland, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team :

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr's new chapter in Warsaw, Poland. Together, we can shape the future of regulatory solutions.

To Apply :

Please apply to this job post or you can visit our Careers page for more openings

Visit our Careers page at (https : / / www.freyrsolutions.com / careers / current-positions) to explore current job openings and submit your application.

Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!

Job Title : RIMS Support Specialist / Coordinator / Manager

Location : Remote

Job Type : Full-Time, Permanent

Job Overview :

We are seeking a highly skilled RIMS Specialist with experience in Regulatory Information Management Systems (RIMS) and Veeva Vault. The ideal candidate will have a foundational understanding of Regulatory Affairs (RA) processes and will be responsible for supporting regulatory activities, ensuring compliance with global regulatory requirements, and managing data within RIMS and Veeva systems.

Key Responsibilities :

Regulatory Information Management (RIMS) :

  • Manage and maintain regulatory data within RIMS to ensure accuracy and compliance with global regulatory standards.
  • Coordinate with internal and external stakeholders to ensure timely updates and submissions within the RIMS platform.

Veeva Vault Management :

  • Utilize Veeva Vault for document management, tracking regulatory submissions, and maintaining regulatory records.
  • Ensure all regulatory documents are properly stored, updated, and accessible in Veeva Vault according to internal processes and external regulations.

    • Regulatory Affairs Support :

  • Provide support to the Regulatory Affairs team in preparing, reviewing, and submitting regulatory documents to health authorities.
  • Assist in the development and implementation of regulatory strategies for product approvals and compliance.
  • Stay updated on global regulatory requirements and ensure company practices align with current regulations.

    • Compliance & Documentation :

  • Ensure all regulatory documents and submissions comply with applicable regulations and standards.
  • Assist in maintaining up-to-date regulatory files and records, ensuring easy access and retrieval of information.

    • Collaboration & Communication :

  • Work closely with cross-functional teams, including Quality Assurance, Clinical, and Manufacturing, to support regulatory activities.
  • Communicate effectively with internal teams and external regulatory agencies to facilitate smooth regulatory processes.

    • Qualifications :

    Education : Bachelor’s degree in Life Sciences, Pharmacy, or a related field. Advanced degree preferred.

    Experience :

  • Experience in Regulatory Affairs, with specific experience in using RIMS and Veeva Vault.
  • Basic understanding of Regulatory Affairs processes and global regulatory requirements.

    • Skills :

  • Strong organizational skills and attention to detail.
  • Excellent communication skills, both written and verbal.
  • Ability to work collaboratively in a fast-paced, dynamic environment.
  • Proficiency in RIMS and Veeva Vault systems.

    • Benefits :

  • Competitive salary.
  • Comprehensive health and wellness benefits.
  • Opportunities for professional growth and development.
  • Flexible work environment and support for work-life balance.

    • Join our team at Freyr Life Sciences and make a significant impact in the world of Regulatory!