Job Title: RAPD Associate II in Regulatory Affairs
Company: Pfizer
Location: Chennai
Salary: ₹3L–₹7L per Year
About Pfizer:
We’re committed to bringing medicines to the world faster without compromising 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.
Position Summary:
As a RAPD Associate II, you will represent Pfizer as an approval liaison in the regulatory affairs team. This critical role involves providing strategic product direction, interacting with regulatory agencies, and expediting the approval of pending registrations.
Key Responsibilities:
| Responsibility | Description |
|---|---|
| Regulatory Liaison | Act as the regulatory representative on project teams throughout the product lifecycle, interacting with marketing, research teams, and government regulatory agencies. |
| Documentation | Develop and finalize Global Regulatory Strategy Documents (GRSD) and Comparative Toxicogenomics Database (CTD) sections for Lifecycle Management (LCM) submissions. |
| Team Collaboration | Provide regulatory support to cross-functional teams, participate in technical reviews, and offer strategic input on regulatory submissions. |
| Compliance | Ensure team adherence to submission standards, procedures, and policies established by Global Regulatory Affairs. |
| Promotional Material | Provide regulatory inputs for the approval of promotional materials in line with applicable regulations and Pfizer policies. |
| Risk Management | Identify and assess regulatory risks, communicating them to the team to mitigate potential issues. |
| Filing Strategies | Define and execute filing strategies to meet Board of Health (BoH) requirements and ensure dossiers are submission-ready. |
| Regulatory Commitments | Track and ensure commitments made to health authorities are fulfilled. |
| Process Improvement | Manage continuous improvement of processes related to human health submissions and selected projects. |
| Approval Timeliness | Ensure timely approval according to the product registration plan. |
| Database Management | Maintain regulatory databases to ensure compliance. |
| Regulatory Environment | Stay updated on external regulatory environment, including competitor intelligence, and local and international regulatory and commercial strategies. |
Qualifications:
| Requirement | Description |
|---|---|
| Education | B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc in Lifesciences. |
| Experience | 0 to 5 years in regulatory affairs or drug development. |
| Regulatory Knowledge | Understanding of regulations and guidelines in various markets. |
| Stakeholder Management | Strong relationships with local health agencies and stakeholders, proactive issue management. |
| Skills | Good communication, collaboration, negotiation, and problem-solving skills. Fluent in English. |
| Technical Proficiency | Computer literacy and ability to learn new systems. |
Nice-to-Have:
| Additional Skills | Description |
|---|---|
| Regulatory Processes Knowledge | Familiarity with regulatory processes and documents. |
| Therapeutic Areas | Knowledge of therapeutic areas. |
| Strategic Thinking | Strategic thinking with good project management skills. |
How to Apply:
Interested candidates who meet the qualifications are invited to send their CVs to 📧 info@pfizer.com