Pfizer

Director, Global Regulatory Sciences

Pfizer

Cambridge, MA, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Are you a seasoned leader with a deep knowledge of global regulatory sciences? Are you looking for an opportunity to make a meaningful impact on the development and approval of innovative medicines? If so, we have a role that may be perfect for you.Pfizer is seeking a highly experienced Director to lead our Global Regulatory Sciences team. In this role, you will be responsible for developing and implementing global regulatory strategies for our diverse portfolio of products. This is a unique opportunity to shape and influence the global regulatory landscape and drive the success of our company.To excel in this role, you must have a proven track record of success in regulatory affairs, as well as strong leadership skills and the ability to navigate complex regulatory environments. If you are a strategic thinker, with a passion for driving regulatory excellence, we encourage you to apply for this exciting opportunity. Join us in our mission to bring life-changing medicines to patients around the world.

  1. Develop and implement global regulatory strategies for Pfizer's diverse portfolio of products.
  2. Lead and manage the Global Regulatory Sciences team, providing guidance, support, and direction to ensure the team's success.
  3. Stay current with global regulatory requirements and changes, and proactively identify potential regulatory risks and opportunities.
  4. Collaborate with cross-functional teams to ensure regulatory compliance and timely approvals for product development and commercialization.
  5. Serve as the primary point of contact for regulatory agencies and represent Pfizer in interactions and negotiations with regulatory authorities.
  6. Provide strategic input and guidance to product development teams regarding regulatory requirements, potential risks, and mitigation strategies.
  7. Oversee the preparation, submission, and maintenance of regulatory documents and dossiers for global markets.
  8. Lead regulatory intelligence efforts to monitor and assess the competitive and regulatory landscape, and provide recommendations to senior leadership.
  9. Work closely with internal and external stakeholders, including business partners, key opinion leaders, and external regulatory consultants.
  10. Mentor and develop team members to ensure a high level of regulatory expertise and performance.
  11. Collaborate with other departments, such as R&D, Legal, and Commercial, to ensure alignment and consistency in regulatory strategies and activities.
  12. Drive continuous improvement initiatives to optimize regulatory processes and ensure compliance with regulatory requirements.
  13. Represent Pfizer at industry conferences and events to share knowledge and expertise and stay updated on current trends and best practices in global regulatory affairs.
  14. Serve as a key member of the leadership team and contribute to the overall strategic direction of the company.
  15. Uphold Pfizer's values and promote a culture of excellence, integrity, and compliance within the Global Regulatory Sciences team.
Where is this job?
This job is located at Cambridge, MA, USA
Job Qualifications
  • Extensive Knowledge Of Global Regulatory Requirements And Guidelines: The Ideal Candidate For This Position Should Have A Deep Understanding Of Global Regulatory Requirements And Guidelines, Including Those Of Major Markets Such As The Us, Eu, And Japan.

  • Strong Leadership Skills: As A Director, Global Regulatory Sciences, The Candidate Will Be Responsible For Leading A Team Of Regulatory Professionals And Coordinating With Cross-Functional Teams. Therefore, Strong Leadership Skills Are Essential For Effectively Managing And Motivating A Team.

  • Experience In Drug Development And Submission Processes: A Successful Candidate Should Have Experience In Drug Development And Submission Processes, Including Ind, Nda, And Maa Submissions. This Will Enable Them To Provide Strategic Input And Ensure Regulatory Compliance Throughout The Product Development Lifecycle.

  • Excellent Communication And Interpersonal Skills: The Role Of Director, Global Regulatory Sciences Involves Extensive Communication With Regulatory Agencies, Internal Stakeholders, And External Partners. The Candidate Should Be Able To Effectively Communicate Complex Regulatory Information And Build Strong Relationships With Stakeholders.

  • Advanced Degree In A Relevant Field: A Degree In Pharmacy, Life Sciences, Or A Related Field Is Typically Required For This Position. An Advanced Degree, Such As A Phd Or Pharmd, Is Preferred And Demonstrates A Strong Foundation In Scientific Principles And Drug Development Processes.

Required Skills
  • Risk Management

  • Quality Assurance

  • Project Management

  • Data Analysis

  • Drug development

  • Team Leadership

  • FDA regulations

  • Regulatory Affairs

  • Clinical Trials

  • Regulatory Strategy

  • Pharmaceutical Industry

  • Global Compliance

Soft Skills
  • Communication

  • Conflict Resolution

  • Leadership

  • Time management

  • creativity

  • Organizational skills

  • Teamwork

  • Adaptability

  • Problem-Solving

  • Empathy

Compensation

According to JobzMall, the average salary range for a Director, Global Regulatory Sciences in Cambridge, MA, USA is $179,000 - $245,000 per year. This can vary depending on the specific company, industry, experience level, and other factors.

Additional Information
Pfizer 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 PostedDecember 14th, 2023
Apply BeforeJune 9th, 2026
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About Pfizer

Pfizer Inc. is an American multinational pharmaceutical corporation headquartered in New York City, with its research headquarters in Groton, Connecticut. It is one of the world's largest pharmaceutical companies.

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