Regulatory Affairs Specialist

Welcome to PPD-Pharmaceutical Product Development, a leading global contract research organization in the biopharmaceutical industry. We are currently seeking a highly motivated and experienced Regulatory Affairs Specialist to join our dynamic team. In this role, you will play a crucial role in ensuring compliance with regulatory requirements for our clients' drug development programs. If you are passionate about regulatory affairs and have a strong attention to detail, we invite you to apply for this exciting opportunity. To be successful in this position, you must have a Bachelor's degree in a scientific or healthcare field, with a minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry. Additionally, you should have a thorough understanding of FDA regulations and guidelines, as well as experience in preparing and submitting regulatory submissions. Strong communication and organizational skills are essential, as you will be working closely with cross-functional teams and external stakeholders. Join us at PPD and make a meaningful impact in the advancement of life-saving therapies.

1. Ensure compliance with all regulatory requirements for clients' drug development programs.
2. Prepare and submit regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
3. Stay up-to-date with all relevant FDA regulations and guidelines.
4. Communicate with cross-functional teams and external stakeholders to gather necessary information for regulatory submissions.
5. Review and analyze scientific data to ensure accuracy and compliance with regulations.
6. Collaborate with internal teams to develop and maintain regulatory strategies for drug development programs.
7. Identify and address potential regulatory issues or challenges.
8. Maintain and update regulatory documents and databases.
9. Participate in regulatory audits and inspections.
10. Provide guidance and support to other team members on regulatory affairs matters.
11. Attend relevant conferences and training to stay current on industry developments.
12. Adhere to timelines and prioritize tasks to meet project deadlines.
13. Contribute to process improvement initiatives within the regulatory affairs department.
14. Maintain confidentiality of sensitive information.
15. Represent PPD in a professional and positive manner.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Singapore is S$4,500 - S$7,000 per month. However, this can vary depending on factors such as years of experience, education level, and specific industry. Some companies may also offer additional benefits and bonuses.

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