Associate Ii, Cdm

5 days ago

Chennai, India Pfizer Full time

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

As an associate, your focus on the job will contribute in achieving your team’s tasks and goals. This is a multifaceted role that will offer you a number of opportunities to enhance your skills. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
- Contribute to the completion of project milestones and organize own work to meet project task deadlines.
- Work in compliance and ensure delivery on regulatory benchmarks.
- Work in collaboration across the organization with stakeholders to deliver efficiencies in regulatory submissions and processes.
- Support audit as part of regulatory data and system scope.
- Update the appropriate regulatory requirements systems and database in a timely manner when changes occur in market regulations.
- Perform monthly compliance report review and complete remediation activities in close partnership with Regulatory strategist teams.
- Review audit reports from the systems and resolve errors to ensure integrity of data.
- Responsible for coordinating the labeling updating process of product, to ensure compliance with Pfizer labeling policy and local Board of Health (BoH) regulations.
- Prepare and/or coordinate dossier preparation, guaranteeing quality dossiers, fulfilling country regulations and Pfizer standards in conjunction with regional teams.
- Maintain systems and databases per internal Standard Operating Procedures (SOPs) and policies and adhere to Pfizer compliance standards.
- Review, analyze, coordinate and provide feedback to Head of Regulatory Affairs in matters relating to new product submissions and post approval maintenance of products as required.

**Qualifications**:
Must-Have
- Bachelor's Degree
- Demonstrated experience
- Proven ability to consistently deliver to time, cost and quality standards
- Operational knowledge of hardware and software tools required for the job
- Excellent organizational skills and attention to detail
- Knowledge of documentation practices
- Fluent in English, verbal and written

Nice-to-Have
- Project Management experience
- Knowledge across multiple therapeutic areas

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

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