Regulatory Affairs Associate
Regulatory Affairs Associate
Hetero Healthcare Limited
Job description
Looking to build a career in regulatory affairs at a Hyderabad pharma company? Explore this Regulatory Affairs Associate opening at Hetero Healthcare.
Company Description
Hetero Healthcare Limited is an Indian pharmaceutical company headquartered in Hyderabad, and it is part of the Hetero Group. Now it is hiring for a Regulatory Affairs Associate position. The company works on branded generic medicines for HIV, cancer, heart, nerve, and immune conditions. It aims to improve people’s quality of life through its products and ongoing research, and it uses the Group’s manufacturing strengths.
Job Summary
This Regulatory Affairs Associate role is located in Hyderabad. It welcomes B.Pharm and M.Pharm graduates who have 3 to 6 years of experience in regulatory affairs. You will handle all work, from start to finish, managing ACTD and CTD dossiers, submissions, product registrations, renewals, and variations. You will also answer questions, look over artwork, and work with teams and authorities to make sure approvals come through on time.
Key Responsibilities
As a Regulatory Affairs Associate, you will handle end-to-end regulatory activities, including dossier compilation.
Work on ACTD, CTD, and country-specific checklist needs.
Support dossier submissions for assigned markets.
Manage product registrations and renewals.
Coordinate variation-related regulatory work.
Handle replies to regulatory queries and artwork review.
Make sure of regulatory compliance and check country-specific needs.
Work with cross-functional teams and regulatory authorities for timely approvals.
Educational Qualification
B.Pharm or M.Pharm degree is needed for this Regulatory Affairs Associate role.
Skills Required
3 to 6 years of experience as a Regulatory Affairs Associate.
Knowledge of ACTD and CTD dossiers and country-specific checklists.
Experience with product registrations, renewals, and variations.
Skill in answering regulatory queries and reviewing artwork.
Good coordination skills to work with cross-functional teams and authorities.
Salary Structure
The salary for a Regulatory Affairs Associate at Hetero Healthcare Limited in Hyderabad typically ranges from ₹6.2 Lakhs to ₹9 Lakhs per year.
Career Development
This Regulatory Affairs Associate role lets you handle regulatory activities, from dossier compilation to registrations and renewals, within a Hyderabad-based pharma company. This role also provides experience in country submissions and teamwork with regulatory authorities.
How to Apply
Visit our job portal and search for the Regulatory Affairs Associate role at Hetero Healthcare Limited in Hyderabad.
Interested candidates should send their updated resume to nsreddy@heterohealthcare.com. Mention the Regulatory Affairs role and your years of experience.
Education
Bachelor's Degree
Key Skills
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Start from our Regulatory Affairs resume template, with example points and skills ready to click in. ATS-friendly, and downloads as a PDF.
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.