Intern

2 days ago

Chennai Tamil Nadu, India Pfizer Full time

Why Patients Need You

A career with us is about discovering breakthroughs that change patients’ lives. Whatever your role, you will be part of bringing those therapies to people all over the world. You will be driving the industry forward and making a positive difference. And you will discover that amazing things are possible.

What You Will Achieve

As part of the Global Regulatory Sciences team, you will assist CMC Global Regulatory Strategist - CMC (GRS-CMC) and collaborate with Cross Functional Teams to prepare and submits the CMC submission packages as per defined timelines.

You will participate in activities related to improving processes of your team and collaborate with others by sharing your experiences. Your knowledge and skills will help in making decisions that make the best of limited options.

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

How You Will Achieve It- Manage own time and professional development, be accountable for own results and prioritize workflows.
- Assists CMC strategist in day-to-day regulatory activities associated with assigned activities under the Team Lead guidance and supervision.
- Assists in authoring and/or compilation of CMC submission package under the guidance from Team Lead and CMC GRL as appropriate and within agreed timelines.
- Updates impacted dossier components as needed
- Escalates delays in timelines and flags identified risks to the CMC GRL and/or appropriate leadership
- Coordinates internal document review and sign off.
- Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc., as appropriate.
- Ensures compliance to Pfizer internal procedures and training SOPs (PLA).
- Ensure accountability for the highest levels of compliance to norms, policies and procedures.

Qualifications

Must-Have- Postgraduate in Pharmacy / Science- High attention to detail.- Good interpersonal skills.

Nice-to-Have- Knowledge on Regulatory requirements of post approval changes- Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.- Understanding of both pharma industry and scientific academic research environments.

Work Location Assignment: Hybrid

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

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