PPD-Pharmaceutical Product Development

Manager, Regulatory Affairs

PPD-Pharmaceutical Product Development

Remote
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Are you a highly organized and detail-oriented professional with experience in the pharmaceutical industry? PPD-Pharmaceutical Product Development is seeking a Manager, Regulatory Affairs to join our team. In this role, you will be responsible for leading the development and delivery of regulatory strategies to ensure that all products comply with industry regulations. The ideal candidate will bring an in-depth knowledge of the pharmaceutical industry and experience in managing regulatory affairs teams. If you have a passion for regulatory compliance and are up for the challenge of helping to deliver life-changing products to the world, we want to hear from you!

Responsibilities:

  1. Develop and implement regulatory strategies to ensure that all products comply with industry regulations.
  2. Monitor and provide guidance to the regulatory affairs team throughout the product development and commercialization process.
  3. Track and maintain up-to-date knowledge of applicable regulations and industry standards.
  4. Liaise with external stakeholders to ensure compliance with regulatory requirements.
  5. Prepare, review, and submit regulatory documents to government agencies.
  6. Monitor changes in regulations and ensure compliance with new requirements.
  7. Prepare and deliver presentations on regulatory issues to internal and external stakeholders.
  8. Develop and maintain relationships with regulatory agencies.
  9. Identify and mitigate potential risks associated with regulatory compliance.
  10. Stay abreast of industry trends and best practices in regulatory affairs.
Where is this job?
This job opening is listed as 100% remote
Job Qualifications
  • Excellent Organizational Skills

  • Ability To Manage Multiple Projects Simultaneously

  • Sound Knowledge Of Fda/Regulatory Requirements

  • Experience In Regulatory Strategy And Submission Processes

  • Strong Written And Verbal Communication Skills

  • Ability To Work Effectively In A Team Environment

  • Knowledge Of Drug Development And Clinical Trial Processes

  • Familiarity With Applicable Laws

  • Regulations

  • And Guidelines

Required Skills
  • Documentation

  • Project Management

  • Networking

  • Strategy

  • Communication

  • Time Management

  • Quality

  • Multitasking

  • Problem Solving

  • Negotiation

  • Leadership

  • Compliance

  • Teamwork

  • Analysis

  • Regulatory

Soft Skills
  • Communication

  • Negotiation

  • Time management

  • Interpersonal Skills

  • creativity

  • flexibility

  • Teamwork

  • Strategic thinking

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Manager, Regulatory Affairs is between $82,000 and $106,000 per year. The exact salary will depend on the company, job responsibilities, experience level, and location.

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 9th, 2026
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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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