Country Approval Specialist

PPD-Pharmaceutical Product Development is looking for a highly organized and collaborative Country Approval Specialist to join our team and help ensure the smooth and timely completion of global regulatory submissions.In this role, you will play a vital part in the success of PPD-Pharmaceutical Product Development's drug development program by ensuring that all regulatory submissions are accurate, complete, and compliant with all relevant regulations. To be successful in this position, you must have a keen eye for detail, a thorough understanding of global regulatory requirements, and the ability to work with a wide range of stakeholders from around the world.If you are an experienced regulatory professional who is passionate about contributing to the success of innovative drug development programs, then we encourage you to apply for this position.

Responsibilities:

1. Prepare and submit detailed regulatory submissions to national and international regulatory authorities.
2. Monitor, track, and report on the progress of regulatory submissions.
3. Maintain accurate records of regulatory activities and ensure compliance with applicable regulations.
4. Maintain current knowledge of relevant regulations and standards.
5. Collaborate with internal and external stakeholders to ensure the timely completion of regulatory submissions.
6. Provide guidance and advice to internal and external stakeholders regarding regulatory compliance.
7. Develop and implement policies and procedures to ensure regulatory compliance.
8. Identify potential risks associated with regulatory submissions and develop solutions to mitigate them.
9. Lead meetings and workshops to discuss regulatory strategies and activities.
10. Act as a point of contact for regulatory inquiries from internal and external stakeholders.

According to JobzMall, the average salary range for a Country Approval Specialist is between $41,000 and $69,000 per year. The salary range may vary depending on the experience, location, and employer.

PPD, Inc. is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.