Opportunity to work as Reg CMC Associate at Pfizer- Apply before 30th August 2024

Job Title: Associate-I Regulatory CMC

Join Pfizer, the Global Leader in Biopharmaceutical Innovation

At Pfizer, we are committed to transforming healthcare through groundbreaking approaches that enhance the health and well-being of both people and animals. As a premier biopharmaceutical company, we discover, develop, manufacture, and deliver safe, effective, and high-quality prescription medicines. Our collaborative efforts with healthcare providers, governments, and local communities worldwide enable us to expand access to our medicines and improve healthcare quality and systems support.

Job Summary

As an Associate-I Regulatory CMC, you will play a critical role in Global Regulatory Sciences (GRS-CMC) by assisting Global Regulatory Leads (GRLs) in defining global regulatory submission strategies. Your contributions will ensure timely and high-quality regulatory submissions related to post-approval changes, original applications, global expansion, and license maintenance for new and on-market biosimilar, biologic, and small molecule products. You will also support manufacturing plants and manage compliance issues.

Key Responsibilities

• Regulatory Support: Provide regulatory expertise for biosimilars, biologics, and small molecule development projects, collaborating with project leads, cross-functional teams, local and regional regulatory colleagues, external partners, and global health authorities.
• Dossier Management: Prepare and maintain core dossiers for original applications and subsequent changes, ensuring compliance with moderate technical and regulatory complexity. Coordinate quality query responses to deficiency letters from health authorities.
• Strategy & Submission: Independently drive global regulatory strategies for post-approval changes and global expansion submissions. Author quality and timely CMC contributions for license maintenance activities, including US Annual Reports, Renewals, APRR, YBPR, and more.
• Regulatory Guidance: Provide regulatory advice on biologics, biosimilars, and small molecule programs, negotiating submission data requirements and influencing cross-functional teams to meet deliverable dates.
• Regulatory Compliance: Ensure compliance with global regulatory standards, procedures, and policies. Suggest and implement system improvements to enhance regulatory compliance, reduce cycle time, and increase efficiency.
• Mentorship: Guide and mentor new team members on the technical aspects of regulatory requirements and Pfizer’s systems and tools.

Candidate Profile

• Educational Background: Bachelor’s or Master’s degree in Biotechnology, Pharmacy, or Science, or a Ph.D. in Biotechnology/Biological Sciences.
• Experience: 3-5 years of experience in the pharmaceutical industry, particularly in regulatory sciences, with a focus on global submissions and life-cycle management. Experience with sterile injectable submissions is a plus.
• Skills: Strong communication skills, problem-solving abilities, and a proactive, results-oriented approach. Knowledge of global regulatory requirements, ICH guidelines, and the pharmaceutical industry is essential.
• Additional Knowledge: Understanding of CMC regulatory policies and the ability to interpret and apply these in assigned projects.

Additional Information

• Experience: 3-5 Years
• Qualification: M.Pharm, B.Pharm, M.Sc, or Ph.D.
• Location: Chennai
• Industry Type: Pharma / Healthcare / Clinical Research
• Application Deadline: 30th August 2024

Join Pfizer and contribute to shaping the future of healthcare. Apply today!

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