Regulatory Affairs Specialist

Welcome to PPD-Pharmaceutical Product Development! We are a leading global contract research organization focused on accelerating the development of life-changing therapies. We are currently seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team. In this role, you will play a critical role in ensuring compliance with regulations and guidelines for drug development and marketing. If you have a strong understanding of regulatory requirements and a passion for driving innovation in the pharmaceutical industry, we want to hear from you.

1. Ensure compliance with all relevant regulations and guidelines for drug development and marketing.
2. Stay up to date on changes in regulatory requirements and communicate any updates to relevant team members.
3. Coordinate and prepare regulatory submissions for drug development and marketing, including INDs, NDAs, and other relevant documents.
4. Communicate with regulatory agencies to obtain necessary approvals and resolve any issues or concerns.
5. Review and approve labeling, promotional materials, and other documents to ensure compliance with regulatory requirements.
6. Work closely with cross-functional teams to ensure regulatory compliance throughout the drug development process.
7. Provide regulatory guidance and support to other team members and departments.
8. Participate in regulatory agency inspections and audits, as needed.
9. Identify potential regulatory risks and develop strategies to mitigate them.
10. Collaborate with internal and external stakeholders to facilitate timely and successful regulatory submissions.
11. Maintain accurate and up-to-date records and documentation related to regulatory activities.
12. Continuously evaluate and improve regulatory processes to increase efficiency and effectiveness.
13. Represent the company in external meetings and conferences related to regulatory affairs.
14. Stay informed about industry trends, changes in regulations, and best practices in regulatory affairs.
15. Uphold PPD's values and promote a positive work culture within the regulatory affairs team.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Waltham, MA, USA is $75,000 - $110,000 per year. This may vary depending on the specific company, experience level, and other factors. Some specialists in this field may also receive bonuses or other forms of compensation.

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