Pfizer Inc.- Pfizer Essential Health Global Regulatory Affairs (PEH GRA)

Pfizer Inc. is an American pharmaceutical corporation headquartered in New York City, with its research headquarters in Groton, Connecticut. It is one of the world's largest pharmaceutical companies. It is listed on the New York Stock Exchange, and its shares have been a component of the Dow Jones Industrial Average since 2004. Pfizer ranked No. 57 on the 2018 Fortune 500 list of the largest United States corporations by total revenue.

The company develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, endocrinology, and neurology. Its products include the blockbuster drug Lipitor (atorvastatin), used to lower LDL blood cholesterol; Lyrica (pregabalin) for neuropathic pain and fibromyalgia; Diflucan (fluconazole), an oral antifungal medication; Zithromax (azithromycin), an antibiotic; Viagra (sildenafil) for erectile dysfunction; and Celebrex (also Celebra, celecoxib), an anti-inflammatory drug.

Trainee Executive

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.

Job Description/ Requrement:

• 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.
• Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled 
• Reviews 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/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            (Power 2 Learn).

Requirements:

• Knowledge on 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 company’s and regulatory agency databases.
• Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.

Qualifications :
Preferred Education:
Minimum – Postgraduate in Pharmacy / Science

Preferred Attributes:
Excellent oral and written English communication skills. Good conceptual and reasoning skills. Attention to details.

Work Location: Chennair

How to Apply: Complete the online job application form HERE

Deadline: -

Source: HERE