Sme-reg Affairs-med Writing

2 weeks ago

Singapore Cognizant Full time

**Job Summary**

**Responsibilities**
- Develop comprehensive regulatory documents and submissions to ensure compliance with global regulations and standards.
- 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 regulatory purposes.
- Conduct thorough research and analysis to support regulatory strategies and decision-making processes.
- Ensure all regulatory documentation is accurate complete and submitted in a timely manner.
- Maintain up-to-date knowledge of regulatory requirements and industry trends to inform best practices.
- Provide expert guidance on regulatory affairs and medical writing to internal stakeholders.
- Review and edit regulatory documents to ensure clarity accuracy and compliance with guidelines.
- Coordinate with research and development teams to align regulatory strategies with project goals.
- Monitor and track regulatory submissions and approvals to ensure project timelines are met.
- Support the development and implementation of regulatory policies and procedures.
- Communicate effectively with regulatory agencies and external partners to facilitate approvals.
- Contribute to the continuous improvement of regulatory processes and documentation standards.

**Qualifications**
- Demonstrate proficiency in MS Excel and MS Office for regulatory documentation and reporting.
- Exhibit strong understanding of Regulatory Business Process Services and Regulatory Affairs.
- Possess experience in Research and Development within the regulatory domain.
- Show ability to work collaboratively in a hybrid work model.
- Have a keen eye for detail and accuracy in regulatory documentation.

**Certifications Required**

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

LI-CTSAPAC

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