You will represent Pfizer as an approval liaison in the regulatory affairs team. Your critical role will involve providing strategic product direction to teams, interacting with regulatory agencies, and negotiating to expedite the approval of pending registrations. You will be the regulatory liaison on project teams throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will assist in developing submissions for product registration, progress reports, supplements, amendments, and periodic experience reports.
As an associate, your focus will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative environment for your colleagues. Your hard work and focus will help Pfizer achieve new milestones and assist patients globally.
How You Will Achieve It:
- Contribute to the completion of project milestones and organize your work to meet project task deadlines.
- Ensure team 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, ensuring effective data presentation and quality, by yourself or under guidance.
- Provide regulatory support to cross-functional teams for assigned products, participate, and provide inputs in technical reviews and 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 communicate timely to the team to mitigate risks.
- Liaise with key stakeholders to define and execute filing strategies, ensuring Board of Health (BoH) requirements are met, and dossiers are submission-ready.
- Ensure commitments made to health authorities are tracked to closure.
- Manage continuous improvement of processes related to human health submissions and selected projects.
- Ensure timely approval according to the product registration plan.
- Maintain regulatory databases to ensure compliance.
- Stay updated on 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 relationship with local health agencies and relevant stakeholders, pro-actively managing issues with key external stakeholders
- Good communication, collaboration, negotiation, and problem-solving skills
- Fluent in English, written and spoken
- Computer literacy and ability to learn new systems
Nice-to-Have:
- Knowledge of regulatory processes and documents, and knowledge of therapeutic areas
- Strategic thinking with good project management skills