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142 Hetero Jobs
Assistant Manager
8-12 years
₹ 6L/yr - 13L/yr (AmbitionBox estimate)
This is an estimate of the average salary range for this
position. It has not been reviewed by the company, and
the actual salary may differ.
Hyderabad / Secunderabad, Jadcherla
1 vacancy
Assistant Manager
Hetero
posted 3 days ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions.
- Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines.
- Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions.
- Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines.
- Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation.
- Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions.
- Prepare regulatory documents for GMP inspections, tender submissions, and related regulatory filings.
- Stay updated with regional regulatory developments, including changes in biopharmaceutical regulations and evolving health authority expectations.
- Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements.
- Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines.
- Support the development of regulatory strategies for new product launches and geographic expansion within Asia.
- Ensure compliance with global and local regulatory SOPs and documentation standards.
Employment Type: Full Time, Permanent
Read full job description
What people at Hetero are saying
Rating based on 134 Assistant Manager
reviews
Anonymous · Production, Manufacturing & Engineering
in Visakhapatnam
Likes
Nothing to like.
Dislikes
Work culture in company is poor.manager team is unqualified.a person named venu prakash tortures subordinates.there is no certain timing to come out from company.whenrver rain falls water gets accumulated abd flows like a lake in that only employees should walk and go.no proper drainage system.
Assistant Manager salary at Hetero
reported by
596
employees
with 8-16
years exp.
₹5.5
L/yr - ₹13
L/yr
5%
more
than the average Assistant Manager Salary in India
View more details
What Hetero employees are saying about work life
based on 3.7k employees
Flexible timing
Monday to Saturday
Within city
Day Shift
Hetero Benefits
Submitted by Company
Employee Friendly Policies Personal Development and Training Reward and Recognition Recreation and Sports Events Unique Benefits Health/Life/Medical Insurance
Submitted by Employees
View more benefits 
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Hetero Hyderabad / Secunderabad Office Location
Hyderabad / Secunderabad, Telangana Office
Headquarter
Floor 9-11, Tower 30, RMZ Nexity, Sy. No. 83/1, Knowledge City, Raidurg, Hyderabad - 500081, Telangana, India
Hyderabad / Secunderabad, Telangana
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