Associate II, Regulatory Strategy, GRS Oncology
Associate II, Regulatory Strategy, GRS Oncology
Pfizer
Job description
Looking to build a career in oncology regulatory strategy? Explore this Associate II, Reg Strategy, GRS Oncology role at Pfizer in Chennai.
Company Description
Pfizer is a global healthcare company driven by a culture of individual ownership and shared purpose. The team has faith in its power to shape the future of healthcare. It wants to change lives across the globe. The Company keeps looking for treatments that can truly help patients, in every corner of the world. Pfizer continues to explore innovative therapies that can make a real difference for patients everywhere. The company welcomes new talent eager to grow within its global regulatory community.
Job Summary
This hybrid role sits within the Global Regulatory Strategic Team, focused on oncology products. As an Associate II, you will work with Global Regulatory Leads on lifecycle maintenance submissions for a specific region, such as the US, EM, or EU. Your work will span CMC document preparation, safety compliance reporting, and submission operations. The role also involves close coordination across global, regional, and country teams.
Key Responsibilities
Coordinate lifecycle activities like variations, renewals, amendments, and post approval commitments.
Help lead regional regulatory strategies in line with commercial goals.
Keep regulatory positions aligned across global, regional, and country stakeholders.
Author and quality check eAF CMC applications, cover letters, and submission packages.
Check eAF CMC content for accuracy against the approved regulatory strategy.
Prepare and quality check submission components, including forms and response documents.
Support responses to Health Authority questions with clear, timely input.
Coordinate labeling updates, including impact checks and submission planning.
Support aggregate safety reports and post authorization commitments.
Generate Pearl and WWRS reports for renewals, launches, and health authority queries.
Maintain strong working relationships across regulatory, clinical, safety, and commercial teams.
Take part in project meetings and follow through on assigned actions.
Educational Qualification
Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related field.
A Master's degree in Pharmacy, Regulatory Affairs, or a related field is preferred.
Skills Required
2 to 4 years of relevant regulatory experience in the pharmaceutical industry.
Strategic mindset with strong critical thinking and data driven decision making.
Working knowledge of regulatory submissions and product lifecycle management.
Experience preparing or reviewing regulatory submission documents and trackers.
Ability to manage multiple priorities in a global matrix environment.
Strong written and verbal communication skills for varied audiences.
Good presentation skills across different meeting formats.
Experience in oncology, specialty care, or biologics is a plus.
Familiarity with eAF, electronic submission tools, or regulatory information systems is helpful.
Knowledge of EM, EU, or US regulatory frameworks is an advantage.
Salary Structure
The average salary for an Associate II Regulatory Strategy role at Pfizer in India typically ranges from ₹5 Lakhs to ₹7 Lakhs per year.
Career Development
This role offers hands on exposure to global oncology regulatory strategy within a leading healthcare company. Pfizer also supports long term growth through mentorship, cross functional collaboration, and opportunities to advance across regulatory affairs.
How to Apply
Visit our job portal and search for the Associate II, Reg Strategy, GRS Oncology role in Pfizer.
Click on the listing to view the complete job details.
Fill in your information and upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.