
Principal Regulatory Affairs Specialist
At PPD-Pharmaceutical Product Development, we are looking for a talented individual to join our team as a Principal Regulatory Affairs Specialist. You will be at the forefront of helping us develop and maintain our regulatory strategy for our products.The successful candidate will have extensive knowledge and experience in the pharmaceutical industry, along with a proven track record in managing and submitting regulatory submissions. With excellent communication skills, you will be able to effectively collaborate with multiple teams across PPD-Pharmaceutical Product Development. You must have the ability to work autonomously and be comfortable with making decisions that will affect the success of our products.The ideal candidate will have a Bachelor’s Degree in a relevant field, such as Regulatory Affairs, Pharmaceutical Science, or Chemistry, and at least 8 years of experience in Regulatory Affairs. You should also have experience in both US and European Regulatory Affairs, and a deep understanding of the regulatory environment.We are looking for a passionate and motivated individual who can bring fresh ideas and insights to the team and help us build and maintain our regulatory strategy. If this sounds like you, we would love to hear from you.
Responsibilities:
- Developing and maintaining regulatory strategy for products.
- Submitting regulatory submissions.
- Collaborating with multiple teams across PPD-Pharmaceutical Product Development.
- Making decisions that will affect the success of products.
- Possessing extensive knowledge and experience in the pharmaceutical industry.
- Having experience in both US and European Regulatory Affairs.
- Having a deep understanding of the regulatory environment.
- Bringing fresh ideas and insights to the team.
Excellent Written And Verbal Communication Skills
Detail Oriented
Strong Organizational Skills
Knowledge Of Applicable Laws And Regulations
Regulatory Affairs Experience
Regulatory Affairs Certification
Ability To Prioritize And Work Under Tight Timelines
Working Knowledge Of Gcp And Gxp
Documentation
Project Management
FDA
Compliance
Drug development
GCP
Negotiations
GLP
Regulatory
Clinical Trials
Processes
Audits
Regulatory Strategy
Submissions
Interactions
Communication
Leadership
Negotiation
Time management
Interpersonal Skills
flexibility
Critical thinking
Organizational skills
Teamwork
Problem-Solving
According to JobzMall, the average salary range for a Principal Regulatory Affairs Specialist is $110,000 to $140,000 per year. This salary range can vary depending on the individual's experience, location, and other factors. Generally, those with more experience will earn higher salaries.
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PPD, Inc. is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

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