Trainee Executive-Annual Report Strategist null

About Pfizer

Pfizer Healthcare India Private Limited (PHIPL) is a legal entity incorporated under the provisions of the Companies Act, of 1956. It is an export-oriented undertaking of Pfizer Inc. They are committed to living their purpose, ‘Breakthroughs That Change Patients’ Lives’. It is grounded in their commitment to fund programs that provide public benefit, advance medical care, and improve patient outcomes. Their belief is, that all people deserve to live healthy lives. This drives the desire to provide access to medicines that are safe, effective, and affordable.

Your role

Position Purpose:

Functions as an Annual Report Strategist for Brands-NDA Annual Report (AR) team, working with CMC Global Regulatory Strategist - CMC (GRS-CMC) and Cross-Functional Teams to prepare and submits the CMC contributions of US NDA/ANDA/BLA/PMA/IND Annual Reports as per defined timelines.

Primary Responsibilities:

• Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed-upon timelines.
• Reviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the CMC GRL.
• Authors and/or compiles CMC contributions based on changes made during the appropriate reporting period, i.e. Module 1 & 3 under the guidance from the CMC GRL as appropriate and within agreed timelines.
• Review all appropriate systems for post-approval changes submitted and approved along with commitments made and fulfilled 
• Review technical/supportive information for submission to support AR changes
• Manages and reviews stability contributions for accuracy and consistency with commitments
• Reviews and applies pertinent US regulatory guidelines to confirm Annual Reportable filing classifications.
• Develops technical justification of change for agency submission as needed
• Updates impacted dossier components as needed
• Coordinates M3.2.R Ancillary documents as needed
• Escalates delays in timelines and flags identified risks to the CMC GRL and appropriate leadership
• Coordinates internal document review and sign-off.
• Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc., as appropriate.
• Ensures compliance with Pfizer internal procedures and training SOPs       

Training, development & rotations

Whether you’re a recent graduate, or at college and looking for a summer placement, discover their range of programs designed to help you learn, develop and make an impact in a truly world-class company. You can be confident you’ll thrive too, whatever your background. Pfizer is committed to empowering every colleague to create their growth journey to unleash their potential, propel themselves forward, and deliver on their purpose.

Salary & benefits

The annual salary for the Trainee Executive-Annual Report Strategist at this company can range from INR 3.6 to INR 4.9 LPA. (Source: Ambition Box).

Pfizer offers competitive compensation and benefits based on a variety of factors including prior experience, geographic location, and talent pool availability:

• Pay for Performance Philosophy and Practices
• Benefits to Maintain and Promote Health and Wellness
• Benefits to Help Colleagues Meet Financial Goals
• Breakthrough Benefits for the moments that matter

To learn more about the benefits provided by Pfizer click here

Career progression

Pfizer has transformed growth and development to ensure that everyone can follow the path to their dream career. As a Pfizer colleague, you may focus on being the best in your current role (Grow in Role), grow your knowledge, and develop a stronger foundation in a specific area. You might use your expertise on a new project or in a new role to create a broader perspective of your function or discipline (Next Experience). You may step up to a different part of the business to expand your view of Pfizer (Cross-Functional), or to a position of greater responsibility and challenge (Next Level). How you grow is determined by you.

Work-life balance

Pfizer has a good, inclusive work environment and a diverse working culture, one of the best in the industry. They always take care of their employees and their working lives.

Culture & vibe

Pfizer is a professional, international company with a strong focus on research and development. The company offers a wide range of career opportunities for talented and ambitious employees. Pfizer is committed to inclusion and diversity in the workplace. The company has a range of initiatives in place to support employees from all backgrounds.

About you

The requirements for the role are as follows:

Technical Skill Requirements

• Knowledge of Regulatory requirements of post-approval changes for US Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of ARs.
• Knowledge in retrieving information from the company and regulatory agency databases.
• Basic level of knowledge of general standards, processes, and policies of the Pfizer/Pharmaceutical manufacturing Industry.

Preferred Education

• Minimum – Postgraduate in Pharmacy / Science

Preferred Attributes

• Excellent oral and written English communication skills. Good conceptual and reasoning skills. Attention to detail.

How to apply

To apply for this role, simply click the "Apply on employer site" button on this page to submit your application with Pfizer.

• Wherever you are on your career path, Pfizer has opportunities to help you fulfill your goals and reach your destination.
• Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.