Description

Job Summary

Data. We are seeking a skilled SME in Regulatory Affairs and Medical Writing with 3 to 6 years of experience to join our dynamic team. The ideal candidate will excel in using MS Excel and MS Office and possess strong expertise in Regulatory Business Process Services Regulatory Affairs and Research and Development. This hybrid role requires a native English speaker with excellent communication skills to contribute effectively to our projects.

Responsibilities

• Develop comprehensive regulatory documents that meet industry standards and regulatory requirements.
• Collaborate with cross-functional teams to ensure accurate and timely completion of regulatory submissions.
• Utilize MS Excel and MS Office to organize and analyze data for regulatory documentation.
• Conduct thorough research to support regulatory submissions and ensure compliance with relevant guidelines.
• Provide expert guidance on regulatory business processes and ensure alignment with company objectives.
• Prepare and review scientific documents to ensure clarity accuracy and consistency.
• Maintain up-to-date knowledge of regulatory affairs and industry trends to inform strategic decision-making.
• Communicate effectively with stakeholders to facilitate the regulatory approval process.
• Ensure all documentation is prepared in accordance with company and regulatory standards.
• Support the development of regulatory strategies to optimize product approval timelines.
• Oversee the preparation of responses to regulatory agencies inquiries.
• Contribute to the continuous improvement of regulatory processes and documentation practices.
• Ensure compliance with all relevant regulations and guidelines in a hybrid work model.

Qualifications

• Demonstrate proficiency in MS Excel and MS Office for data management and documentation.
• Possess strong knowledge of regulatory business process services and regulatory affairs.
• Exhibit expertise in research and development within the regulatory domain.
• Communicate fluently in English both written and spoken to effectively engage with stakeholders.
• Have a keen eye for detail and the ability to produce high-quality regulatory documents.
• Stay informed about the latest developments in regulatory affairs and medical writing.

Certifications Required

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