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Regulatory Affairs Specialist for Global Product Development
2 months ago
Company Overview
Pfizer is a global pharmaceutical company that aims to bring medicines to the world faster, while maintaining excellence and integrity.
About the Role
We are seeking a Regulatory Affairs Specialist to join our team in On Premise. As a key member of our regulatory affairs team, you will play a critical role in providing strategic product direction to teams while interacting with regulatory agencies and negotiating to expedite approval of pending registrations.
Your Responsibilities
- Represent Pfizer as an approval liaison in the regulatory affairs team, providing strategic product direction to teams.
- Negotiate with regulatory agencies to expedite approval of pending registrations.
- Develop submission of product registration, progress reports, supplements, amendments and periodic experience reports.
- Contribute to project milestones, organize work, and meet project task deadlines.
- Ensure compliance with submission standards, procedures, and policies framed by Global Regulatory Affairs.
- Prepare and finalize Global Regulatory Strategy Documents (GRSD), Comparative Toxicogenomics Database (CTD) sections of supplements/variations for Lifecycle Management (LCM) submissions.
- Provide regulatory support to cross-functional teams for assigned products, participating in technical reviews and strategic discussions on regulatory submissions.
- Identify and assess regulatory risks associated with assigned projects and communicate timely to mitigate risks.
- Liaise with stakeholders to define and execute filing strategies, ensuring a submission-ready dossier.
- Maintain tracking systems to ensure commitments made to health authorities are entered into and tracked to closure.
Requirements
- Bachelor's Degree
- Proven ability to manage complex regulatory or drug development issues
- Knowledge of regulations and guidelines in various markets
- Strong relationships with local health agencies and other relevant stakeholders
- Good communication, collaboration, negotiation, and problem-solving skills
- Fluent in English, written and spoken
- Computer literacy and ability to learn new systems
Salary Information
The estimated salary for this role is $120,000 - $180,000 per year, depending on qualifications and location.
Benefits
Pfizer offers a comprehensive benefits package, including medical, dental, and vision coverage, 401(k) matching, and paid time off.
Additional Information
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation. This role is located On Premise and requires fluency in English, both written and spoken.
