Great opportunity for M.Pharm Freshers & Experience as Associate at Pfizer-Apply Now

Job Title: Associate I – Reg CMC, Strategy, Brands CMC

Job Location: Chennai

Industry: Pharma / Healthcare / Clinical Research

Experience: 0-1 years

Qualification: Postgraduate in Pharmacy/Science

Application Deadline: July 30, 2023

Job Description: As an Associate I in Regulatory Affairs, you will be responsible for managing the day-to-day regulatory activities associated with assigned Annual Reports (ARs) within agreed-upon timelines. Your key responsibilities will include:

1. Managing Regulatory Activities: You will oversee the regulatory activities related to Annual Reports, ensuring compliance with timelines and requirements.
2. Reviewing Changes and Developing Strategy: You will review changes made during the reporting period for completeness and accuracy. Based on this review, you will develop the initial regulatory strategy for Annual Reports, considering registered content and seeking endorsement from the CMC GRL (Global Regulatory Lead).
3. Authoring and Compiling CMC Contributions: You will author and/or compile CMC (Chemistry, Manufacturing, and Controls) contributions based on changes made during the reporting period. This will involve preparing Module 1 and Module 3 submissions, following the guidance of the CMC GRL and meeting agreed-upon timelines.
4. Reviewing Post-Approval Changes: You will review post-approval changes submitted and approved, along with the commitments made and fulfilled. Additionally, you will review technical/supportive information to support Annual Report changes.
5. Managing Stability Contributions: You will manage and review stability contributions for accuracy and consistency with commitments.
6. Applying Regulatory Guidelines: You will apply relevant US regulatory guidelines to determine the classification of Annual Reportable filings.
7. Developing Technical Justifications: As required, you will develop technical justifications for changes to be submitted to regulatory agencies.
8. Updating Dossier Components: You will update impacted dossier components as needed based on the changes made during the reporting period.
9. Coordinating Ancillary Documents: You will coordinate the preparation of M3.2.R Ancillary documents as needed.
10. Communication and Escalation: You will escalate any delays in timelines and flag identified risks to the CMC GRL and/or appropriate leadership. You will also coordinate internal document reviews and sign-offs.
11. Utilizing Pfizer’s CMC Systems: You will utilize Pfizer’s CMC systems such as GDMS, PDM, SPA, etc., as appropriate for the assigned tasks.
12. Ensuring Compliance: You will ensure compliance with Pfizer’s internal procedures and training SOPs (Standard Operating Procedures) relevant to regulatory affairs.

Candidate Profile: To be considered for this role, you should have the following qualifications and skills:

1. Education: Minimum of a postgraduate degree in Pharmacy or Science.
2. Experience: 0-1 years of experience in an independent role within the Regulatory Affairs function in a reputed pharmaceutical organization.
3. Communication Skills: Excellent oral and written English communication skills.
4. Analytical and Problem-Solving Skills: Good conceptual, analytical, and problem-solving skills.
5. Attention to Detail: Strong attention to detail is required to ensure accuracy in regulatory activities.

Additional Information:

• Knowledge of regulatory requirements for post-approval changes in the US.
• Familiarity with oral solid dosage form and sterile injectable manufacturing and regulatory data requirements for submission of Annual Reports.
• Basic understanding of retrieving information from company and regulatory agency databases.
• Basic knowledge of general standards, processes, and policies of Pfizer and the pharmaceutical manufacturing industry.

If you meet the qualifications and are interested in the position, please submit your application by the deadline of July 30, 2023.