PPD-Pharmaceutical Product Development

Principal Regulatory Affairs Specialist

PPD-Pharmaceutical Product Development

Remote
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

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:

  1. Developing and maintaining regulatory strategy for products.
  2. Submitting regulatory submissions.
  3. Collaborating with multiple teams across PPD-Pharmaceutical Product Development.
  4. Making decisions that will affect the success of products.
  5. Possessing extensive knowledge and experience in the pharmaceutical industry.
  6. Having experience in both US and European Regulatory Affairs.
  7. Having a deep understanding of the regulatory environment.
  8. Bringing fresh ideas and insights to the team.
Where is this job?
This job opening is listed as 100% remote
Job Qualifications
  • 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

Required Skills
  • Documentation

  • Project Management

  • FDA

  • Compliance

  • Drug development

  • GCP

  • Negotiations

  • GLP

  • Regulatory

  • Clinical Trials

  • Processes

  • Audits

  • Regulatory Strategy

  • Submissions

  • Interactions

Soft Skills
  • Communication

  • Leadership

  • Negotiation

  • Time management

  • Interpersonal Skills

  • flexibility

  • Critical thinking

  • Organizational skills

  • Teamwork

  • Problem-Solving

Compensation

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.

Additional Information
PPD-Pharmaceutical Product Development is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedJuly 11th, 2023
Apply BeforeJune 21st, 2025
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About PPD-Pharmaceutical Product Development

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

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