SME-Reg Affairs-Med Writing

Job Summary

We are seeking a Subject Matter Expert in Regulatory Affairs and Medical Writing with 2 to 5 years of experience. The ideal candidate will excel in MS Excel and MS Office and possess strong domain skills in Regulatory Business Process Services Regulatory Affairs and Research and Development. This hybrid role requires a native English speaker with excellent communication skills working in a day shift with no travel required.

Responsibilities

• Develop comprehensive regulatory documents and submissions to ensure compliance with industry standards and regulations.
• Collaborate with cross-functional teams to gather and analyze data for regulatory submissions.
• Utilize MS Excel and MS Office to create detailed reports and presentations for stakeholders.
• Conduct thorough research and analysis to support regulatory strategies and decision-making processes.
• Ensure all regulatory documents are accurate complete and submitted in a timely manner.
• Monitor and interpret regulatory guidelines to provide strategic advice to project teams.
• Communicate effectively with internal and external stakeholders to facilitate regulatory processes.
• Maintain up-to-date knowledge of regulatory requirements and industry trends.
• Assist in the development and implementation of regulatory policies and procedures.
• Provide expert guidance on regulatory affairs and medical writing best practices.
• Contribute to the continuous improvement of regulatory processes and documentation standards.
• Support the preparation and review of clinical trial documents and reports.
• Ensure all activities align with the companys mission to deliver innovative solutions that positively impact society.

Qualifications

• Demonstrate proficiency in MS Excel and MS Office for data management and reporting.
• Exhibit strong domain expertise in Regulatory Business Process Services and Regulatory Affairs.
• Possess a solid understanding of Research and Development processes.
• Show excellent written and verbal communication skills in English.
• Display the ability to work effectively in a hybrid work model.
• Have a keen eye for detail and accuracy in documentation.

Certifications Required

Regulatory Affairs Certification (RAC) or equivalent certification in regulatory affairs.