Pfizer is offering an exciting internship opportunity in Chennai, India, for candidates looking to advance their careers in the Global Regulatory Sciences field. In this role, you will assist in regulatory activities, playing a crucial part in preparing and submitting CMC (Chemistry, Manufacturing, and Controls) submission packages. This is an excellent chance to contribute to Pfizer’s mission of discovering breakthroughs that change patients’ lives.
Why Patients Need You
At Pfizer, every role contributes to bringing life-changing therapies to patients worldwide. As an intern, you will support the development and submission of regulatory documentation, helping ensure these treatments reach those in need.
Key Responsibilities
- Assist the CMC Regulatory Strategist: You will help the CMC Global Regulatory Strategist (GRS-CMC) in the preparation and submission of CMC submission packages as per timelines.
- Collaborate with Cross-Functional Teams: Work closely with internal teams to gather, review, and compile necessary regulatory documents.
- Documentation & Submission: Support in authoring and compiling CMC submission packages under the guidance of the Team Lead, adhering to agreed timelines.
- Compliance & Risk Management: Ensure compliance with Pfizer’s internal procedures and flag any risks or delays to leadership.
- Utilize Pfizer’s CMC Systems: Leverage Pfizer’s CMC systems such as GDMS, PDM, and SPA for managing submissions and documentation processes.
Qualifications and Skills
Must-Have:
- Postgraduate degree in Pharmacy or Science.
- Strong attention to detail.
- Good interpersonal skills and ability to work effectively in teams.
Nice-to-Have:
- Knowledge of regulatory requirements for post-approval changes.
- Basic understanding of the pharmaceutical manufacturing industry’s standards and processes.
- Insight into both the pharmaceutical industry and academic research environments.
How You Will Achieve Success
You will manage your own time and professional development, contributing to the team’s success through efficient task prioritization and collaboration. Your role will directly impact the timely and compliant submission of regulatory documents that help Pfizer achieve new milestones.
Work Location
This position offers a hybrid working arrangement, providing flexibility between working remotely and from the office in Chennai.
