Pfizer Off-Campus Recruitment

Qualifications

Pfizer Off-Campus Recruitment

Required Qualifications & Skills:-

• Bachelor’s Degree
• Proven ability to manage complex regulatory or drug development issues
• Knowledge of the regulations and guidelines in the various markets
• Strong relationship with the local health agency and other relevant stakeholders and pro-actively manages 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

Job Description & Responsibilities:-

• As an associate, your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
• Contribute to the completion of project milestones and organize own work to meet project task deadlines.
• Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs.
• Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), Comparative Toxicogenomics Database (CTD) sections of supplements/variations for Lifecycle Management (LCM) submissions and ensuring effective data presentation and quality, by self or under guidance.
• Provide regulatory support to the cross-functional teams for the 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 timely communicate to the team to quickly mitigate the risks.
• Liaise with key stakeholders to ensure the 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 the product registration plan.
• Maintain the required regulatory databases to ensure compliance.
• Keep abreast of the external regulatory environment, including competitor intelligence, local products and international regulatory and commercial strategies.

Pfizer Off-Campus Recruitment