Upload Button Icon Add office photos
Premium Employer

i

This company page is being actively managed by Hetero Team. If you also belong to the team, you can get access from here

Hetero Verified Tick

Compare button icon Compare button icon Compare
filter salaries All Filters

34 Hetero Jobs

Regulatory Affairs Executive

1-6 years

Balanagar, Hyderabad / Secunderabad

4 vacancies

Regulatory Affairs Executive

Hetero

posted 4hr ago

Job Role Insights

Flexible timing

Key skills for the job

Job Description

The ideal candidate will be responsible for compiling Drug Master Files (DMFs) ensuring compliance with country specific regulatory guidelines in Emerging markets that includes key markets like Brazil, China, Russia, Taiwan etc. This role requires strong coordination with internal stakeholders and expertise in regulatory submissions, amendments, and annual reports.


Key Responsibilities:


  • Prepare and submit regulatory dossiers for emerging markets, including Brazil, China, and LATAM.
  • Participate in deficiency meetings, review pending deficiencies, and collaborate with cross-functional teams to ensure timely submission of responses.
  • Manage and evaluate international regulatory projects in alignment with company goals.
  • Plan, coordinate, and submit regulatory dossiers and responses in regulated markets.
  • Review documents, identify gaps, ensure compliance, and facilitate acceptance meetings.
  • Plan amendments, updates, and annual reports, ensuring accurate compilation, review, and submission.
  • Bachelor's or master's degree in pharmacy, Life Sciences, Chemistry, or a related field.
  • 2-5 years of experience in Regulatory Affairs within the API industry.
  • Strong knowledge of US, EU, and ICH regulatory guidelines.
  • Experience in DMF and CEP compilation, amendments, and annual report filings.
  • Excellent communication and coordination skills to interact effectively with cross-functional teams.
  • Detail-oriented with strong documentation and organizational abilities.
  • Ability to handle multiple regulatory submissions while ensuring accuracy and compliance.





Employment Type: Full Time, Permanent

Read full job description

Prepare for Executive Regulatory Affairs roles with real interview advice

What people at Hetero are saying

2.8
 Rating based on 5 Executive Regulatory Affairs reviews

Likes

I enjoy a positive and fruitful work environment under the guidance of my Assistant Manager, Mr. Hareesh Kumar Reddy Revuri

  • Skill development - Good
Dislikes

I have bad experience with Leave policy

  • Promotions - Poor
  • +2 more
Read 5 Executive Regulatory Affairs reviews

Executive Regulatory Affairs salary at Hetero

reported by 29 employees with 3-7 years exp.
₹3.2 L/yr - ₹7 L/yr
18% more than the average Executive Regulatory Affairs Salary in India
View more details

What Hetero employees are saying about work life

based on 3.3k employees
51%
62%
45%
98%
Flexible timing
Monday to Saturday
Within city
Day Shift
View more insights

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
Job Training
Health Insurance
Soft Skill Training
Free Transport
Cafeteria
Free Food +6 more
View more benefits

Compare Hetero with

Sun Pharmaceutical Industries

4.0
Compare

Cipla

4.1
Compare

DRJ & CO

5.0
Compare

Biocon Limited

3.9
Compare

Lupin

4.2
Compare

Zydus Lifesciences

4.1
Compare

Torrent Pharmaceuticals

3.9
Compare

Glenmark Pharmaceuticals

3.9
Compare

Aurobindo Pharma

4.0
Compare

DIVI'S Laboratories

3.7
Compare

Dr. Reddy's

4.0
Compare

Viatris

4.2
Compare

Abbott

4.1
Compare

Alkem Laboratories

3.9
Compare

Ipca Laboratories

3.9
Compare

MSN Laboratories

3.7
Compare

Micro Labs

3.6
Compare

Akums Drugs & Pharmaceuticals Limited

4.4
Compare

GlaxoSmithKline Pharmaceuticals

4.1
Compare

Pfizer

4.0
Compare

Similar Jobs for you

Executive Regulatory Affairs at Strides Pharma Science

Bangalore / Bengaluru

4-8 Yrs

₹ 5-8 LPA

Executive Regulatory Affairs at Hetero

Hyderabad / Secunderabad

3-8 Yrs

₹ 5-10 LPA

Executive Regulatory Affairs at Strides Pharma Science

Bangalore / Bengaluru

4-8 Yrs

₹ 5-8 LPA

Deputy Regulatory Affairs Manager at Acme Generics

Baddi

7-12 Yrs

₹ 9-16 LPA

Executive Regulatory Affairs at Agio Pharmaceuticals Ltd.

Mumbai

4-6 Yrs

₹ 4-5 LPA

Executive Regulatory Affairs at Viviora Lifesciences

Pune

2-5 Yrs

₹ 2-5 LPA

Regulatory Affairs at Unison Pharmaceuticals

Ahmedabad

7-10 Yrs

₹ 3-8 LPA

Regulatory Affairs at Rusan Pharma

Mumbai Suburban, Mumbai

3-8 Yrs

₹ 2-7 LPA

Drug Regulatory Affairs Executive at Theon Pharmaceuticals

Nalagarh, Baddi + 1

2-7 Yrs

₹ 2.75-7 LPA

Regulatory Affairs at Cadila Pharmaceuticals

Ahmedabad

4-7 Yrs

₹ 4-5.5 LPA

Hetero Hyderabad / Secunderabad Office Location

View all
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
500081

Regulatory Affairs Executive

1-6 Yrs

Balanagar, Hyderabad / Secunderabad

4hr ago·via naukri.com

Regulatory Affairs Executive/ Asst. Manager

3-8 Yrs

Hyderabad / Secunderabad

7hr ago·via naukri.com

Urgent Opening For Factory Medica Officer--Hetero, Nakkapally, Vizag

2-5 Yrs

Visakhapatnam

1d ago·via naukri.com

Walk-in Interview For QC/AR&D @Indore

3-8 Yrs

Baddi

2d ago·via naukri.com

WALK IN Interview For EHS - AM& DM& Manager

8-13 Yrs

₹ 8 - 18L/yr

Hyderabad / Secunderabad

5d ago·via naukri.com

Quality Control- Sr. Executive

4-9 Yrs

₹ 5 - 10L/yr

Jadcherla

9d ago·via naukri.com

Senior Manager-Production

14-20 Yrs

₹ 16 - 18L/yr

Jadcherla

10d ago·via naukri.com

Group Product Manager/International Marketing Manager - SEA

10-20 Yrs

₹ 15 - 30L/yr

Hyderabad / Secunderabad

10d ago·via naukri.com

Executive-Business Development(Europe-FML)

1-4 Yrs

Hyderabad / Secunderabad

10d ago·via naukri.com

Hiring For Warehouse @Hetero-Jadcherla

1-6 Yrs

Jadcherla

11d ago·via naukri.com
write
Share an Interview