Regulatory Affairs Specialist
2 weeks ago
Why Patients Need You
Pfizer is committed to delivering innovative medicines and vaccines to patients worldwide. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring the approval of our products in various markets. Your expertise in regulatory procedures, combined with your ability to communicate effectively with regulatory agencies, will be instrumental in expediting the approval process.
What You Will Achieve
As a Regulatory Affairs Specialist, you will represent Pfizer as an approval liaison, providing strategic product direction to teams while interacting with regulatory agencies. You will be responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD) and Comparative Toxicogenomics Database (CTD) sections of supplements/variations for Lifecycle Management (LCM) submissions. Your attention to detail and ability to manage complex regulatory issues will ensure compliance with regulatory standards and policies.
How You Will Achieve It
- Contribute to the completion of project milestones and organize your work to meet project task deadlines.
- Ensure compliance of the team to the submission standards, procedures, and policies framed by Global Regulatory Affairs.
- Prepare and finalize GRSD and CTD sections of supplements/variations for LCM submissions.
- Provide regulatory support to cross-functional teams for assigned products, participate in technical reviews, and provide inputs in strategic discussions on regulatory submissions.
- Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirements, Pfizer policies, procedures, and practices.
- Identify and assess regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
- Liaise with key stakeholders to ensure filing strategies are defined and executed, and Board of Health (BoH) requirements are met, ensuring a submission-ready dossier.
- Ensure commitments made to health authorities are entered into tracking systems and are tracked to closure.
- Manage continuous improvement of selected processes relating to Human Health submissions and selected drug and non-drug specific projects and related activities.
- Ensure timely approval according to product registration plan.
- Maintain the required regulatory databases to ensure compliance.
- Keep abreast of the external regulatory environment, including competitor intelligence, local product, and international regulatory and commercial strategies.
Qualifications
Must-Have
- 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, proactively managing issues with key external stakeholders
- Good skills in communication, collaboration, negotiation, and problem-solving
- Fluent in English, written, and spoken
- Computer literacy and ability to learn new systems
Nice-to-Have
- Knowledge of regulatory processes and documents, knowledge of therapeutic areas
- Thinks strategically with good project management skills
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