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Pfizer Pharma Jobs for Associate Manager in regulatory affairs

Join Pfizer as an Associate Manager I – Reg CMC Strategy, Brands CMC in Chennai

About Pfizer

Pfizer, a global biopharmaceutical leader established in 1849, is at the forefront of innovation in healthcare. They are dedicated to the exploration, development, production, and distribution of high-quality, safe, and effective prescription medications for both humans and animals. If you’re looking for a challenging career opportunity, consider joining Pfizer’s team as an Associate Manager I in Regulatory Affairs, focusing on CMC strategy for post-approval changes. This role offers an exciting opportunity to contribute to the enhancement of healthcare services on a global scale.

Job Description

As an Associate Manager I in Regulatory Affairs at Pfizer, your role involves developing and executing CMC strategies for post-approval changes worldwide in collaboration with global and regional counterparts. Here are some key responsibilities:

General Responsibilities:

Collaborate with cross-functional teams and support functions as needed.

Utilize regulatory systems and manage CMC documentation and information.

Specific Responsibilities:

Manage day-to-day regulatory activities for assigned projects.
Review proposed changes for completeness and accuracy, developing initial global regulatory strategies.

Author and compile Regulatory Strategy Documents (RSD) and CMC submission packages for Supplements/Variations.
Focus on both Major and Emerging Markets.
Review technical/supportive information for submission.

Apply global regulatory guidelines and develop technical justifications for agency submission.
Coordinate and update M3 dossier and ancillary documents.
Identify and flag risks to appropriate leadership.

Represent the RA CMC perspective and meet with key stakeholders to resolve challenges.
Coordinate internal document review and sign-off.
Utilize Pfizer’s CMC regulatory systems.

Candidate Profile

To qualify for this role, you should meet the following criteria:

Minimum: Postgraduate in Pharmacy or Science (Graduates may be considered based on exceptional merit).
6 to 10 years of CMC experience within a regulatory function.

Knowledge of EU/US and international regulatory practices and policies.
Proficiency in Microsoft Windows, Trackwise, Navigation, or similar submission management tools, document management systems, publishing tools, and operating knowledge of databases.
Strong verbal and written communication skills.

Motivated, with good interpersonal skills.
Organized, hardworking, agile, adaptable to change, and able to meet deadlines.
A team player with the ability to work in a highly matrixed environment.

Customer-focused with a keen eye for detail and accuracy.
Must be able to prioritize tasks with some guidance and handle multiple projects effectively.

Additional Information

Experience Required at Pfizer: 6 – 10 years

Qualification Required at Pfizer: Postgraduate in Pharmacy or Science
Location: Chennai
Industry Type: Pharma / Healthcare / Clinical research

Pfizer Pharma Jobs

If you are a regulatory professional with a passion for advancing healthcare, Pfizer offers an exciting opportunity to make a difference in the pharmaceutical industry. As an Associate Manager I – Reg CMC Strategy, Brands CMC, you will play a pivotal role in Pfizer’s mission to improve global healthcare services. Join Pfizer in Chennai and become part of a diverse and innovative team committed to equal employment opportunity and excellence in the field of Regulatory Affairs.

Don’t miss this chance to take your career to the next level with Pfizer. Apply now!

Apply Now

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