Kukatpally Hyderabad Telangana Regulatory affairs specialist Jobs – 17 Open Jobs Today

Regulatory Affairs Labeling Specialist
Regeneron —Hyderabad, Telangana
- Microsoft Word
- Microsoft Office
- Analysis skills
- Health insurance
- Paid time off
1d
Specialist - Regulatory Affairs - Operations 4B
Genpact India Pvt. Ltd. —Hyderabad, Telangana
- Full-time
- Hybrid work
- English
- Master's degree
- Bachelor's degree
Quick apply
Senior Regulatory Affairs Specialist
Medtronic —Nanakramguda, Hyderabad, Telangana
- Full-time
- Bachelor's degree
- Communication skills
Specialist - Quality Operations
Novartis —Hyderabad, Telangana
- Full-time
- English
- Master's degree
- Bachelor's degree
8d
Senior Associate Corporate Affairs
Amgen —Hyderabad, Telangana
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
GRA Labelling Specialist
Sanofi —Hyderabad, Telangana
- English
- Analysis skills
- Project management
10d
Safety & PV Specialist I
Syneos - Clinical and Corporate - Prod —Hyderabad, Telangana
- Full-time
- Medicine
- B.Sc
- Master's degree
Manager Corporate Affairs
Amgen —Hyderabad, Telangana
- Microsoft Powerpoint
- Master's degree
- Project management
Analytical QA Reviewer
DIFGEN PHARMACEUTICALS PRIVATE LIMITED —Kukatpally, Hyderabad, Telangana
- Full-time
- Analysis skills
- Quality control
- Manufacturing
Regulatory AI & Automation Specialist
Roche —Hyderabad, Telangana
- Full-time
- Azure
- Computer Science
- Master's degree
6d
Product Management Specialist
The U.S. Pharmacopeia (USP) —Hyderabad, Telangana
- Full-time
- Data analysis skills
- Microsoft Office
- Master's degree
- Paid time off
- Flexible schedule
Senior GRA Labeling Specialist
Sanofi —Hyderabad, Telangana
- English
- Analysis skills
- Project management
10d
Safety & PV Specialist I
サイネオス・ヘルス —Hyderabad, Telangana
- Medicine
- B.Sc
- Master's degree
QA Specialist
AVEVA DRUG DELIVERY SYSTEMS INC —Kukatpally, Hyderabad, Telangana
- ₹30 - ₹40 an hour
- Analysis skills
- Bachelor's degree
- Travel
Corporate Legal (Senior Manager)
GVPR —Hyderabad, Telangana
- Master's degree
- Bachelor's degree
- Construction experience
Quick apply
RA Senior Manager OH Category
Haleon —Hyderabad, Telangana
- Full-time
- Agile
- Communication skills
Sr. Specialist - Regulatory Affairs - Operations 4D
Genpact India Pvt. Ltd. —Hyderabad, Telangana
- Full-time
- Hybrid work
- Azure
- English
- Master's degree
Quick apply

Related jobs to explore

Based on your search for regulatory affairs specialist

Regulatory Affairs Labeling Specialist
Regeneron —Hyderabad, Telangana
2+ years of experience in the biotechnology or pharmaceutical industry, preferably in Regulatory Labeling or Regulatory Affairs.
1d
Specialist - Regulatory Affairs - Operations 4B
Genpact India Pvt. Ltd. —Hyderabad, Telangana
Dispatch final documentation package to Regional Regulatory Lead (RRL) for further distribution to LRAs. Provide scientific inputs and actively involved in RA…
Quick apply

I want to receive the latest job alerts for regulatory affairs specialist in kukatpally hyderabad telangana

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory affairs specialist jobs near kukatpally hyderabad telangana

Quality Assurance Analyst jobs in Kukatpally, Hyderabad, Telangana

Quality Specialist jobs in Hyderabad, Telangana

Regulatory Affairs Manager jobs in Hyderabad, Telangana

Product Specialist jobs in Hyderabad, Telangana

Fire Safety jobs in Gujarat

Safety jobs in Goa

Ent Surgeon, Ent Doctor, Ent Specialist, Ms Ent jobs in Delhi, Delhi

Fresher Safety Officer, Hse jobs in Kerala

Quality Engineer jobs in Indore, Madhya Pradesh

Quality Assurance Analyst jobs in Navi Mumbai, Maharashtra

Quality jobs in Puducherry

Quality Assurance Analyst jobs in Hitec City, Hyderabad, Telangana

Quality Assurance Analyst jobs in South Delhi, Delhi, Delhi

Food Quality jobs in Bengaluru, Karnataka

Quality Assurance Analyst jobs in Kanjurmarg, Mumbai, Maharashtra

Data Analyst jobs in Chhattisgarh

Brand Manager jobs in Delhi

Senior Category Manager jobs in Mumbai, Maharashtra

Fitness Manager jobs in Bengaluru, Karnataka

Hr Manager jobs in Noida, Uttar Pradesh

Regulatory Affairs Labeling Specialist

Regeneron -
Hyderabad, Telangana

Apply Now

Job details

1 day ago

Benefits

Health insurance
Paid time off
Life insurance

Qualifications

Microsoft Word
Microsoft Office
Analysis skills
Bachelor's degree
Quality control
Organisational skills
Document management systems
Communication skills
FDA regulations

Full job description

Build Our Future Together

At Regeneron, we believe that the right idea, combined with the right team, can transform lives. Our global teams are dedicated to discovering, developing, and delivering life-changing medicines for people with serious diseases. We are committed to scientific excellence, innovation, and improving patient outcomes worldwide.

We are seeking a Regulatory Affairs Labeling Specialist to join our Regulatory Affairs team in Hyderabad. In this role, you will support global regulatory labeling activities, ensuring compliance, accuracy, and operational excellence across labeling documents, submissions, workflows, and reporting processes. You will collaborate closely with Regulatory Labeling Leads, operations teams, and cross-functional stakeholders to maintain high-quality product labeling and support global regulatory compliance.

When & Where

Location: Hyderabad, India (Hybrid)

Discover Your Role

Support Regulatory Labeling Leads in managing labeling compliance activities and tracking deviations from Company Core Data Sheets (CCDS).
Maintain safety variation trackers, labeling compliance trackers, and other regulatory documentation.
Contribute labeling inputs for annual reports and periodic safety reports (PBRER/PADER) for assigned products.
Conduct competitor labeling analysis using digital tools, including AI-enabled applications.
Perform quality control reviews for EU linguistic reviews and localization activities for SmPCs and Package Leaflets.
Format, hyperlink, proofread, and quality check CCDS, USPI, and SmPC documents according to regulatory standards and checklists.
Perform text comparison, annotation reviews, and cumulative redline preparation for labeling updates.
Create and coordinate Structured Product Labeling (SPL) development, validation, and regulatory submissions.
Support packaging update activities and associated Veeva workflows.
Manage labeling workflows within Veeva and support system updates, testing, and process improvements.
Develop and maintain detailed labeling timelines in Planisware and monitor key deliverables.
Compile labeling metrics, analyze trends, and identify opportunities for automation and process enhancements.
Coordinate Labeling Working Group meetings and maintain critical labeling governance documentation.

This Role Requires

Bachelor’s degree in Life Sciences, Pharmacy, Health Sciences, or a related scientific field.
2+ years of experience in the biotechnology or pharmaceutical industry, preferably in Regulatory Labeling or Regulatory Affairs.
Knowledge of global regulatory requirements and health authorities, including FDA, EMA, and international labeling regulations.
Strong expertise in Microsoft Word and proficiency with Microsoft Office applications.
Experience working with Veeva Vault and regulatory document management systems preferred.
Familiarity with Structured Product Labeling (SPL), labeling quality control, and submission processes.
Experience utilizing AI and digital tools for labeling management is highly desirable.
Excellent attention to detail, organizational skills, and ability to manage multiple priorities simultaneously.
Strong analytical, communication, and stakeholder management skills.
Ability to work independently and collaborate effectively within a global matrix organization.
Regulatory Labeling Operations experience.
Knowledge of SmPC, USPI, CCDS, QRD requirements, and labeling compliance processes.
Experience supporting global product labelsing and lifecycle management activities.
Exposure to automation and digital transformation initiatives within Regulatory Affairs.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Apply Now

Refine Your Search

regulatory affairs specialist jobs in kukatpally hyderabad telangana

Regulatory Affairs Labeling Specialist

Specialist - Regulatory Affairs - Operations 4B

Senior Regulatory Affairs Specialist

Specialist - Quality Operations

Senior Associate Corporate Affairs

GRA Labelling Specialist

Safety & PV Specialist I

Manager Corporate Affairs

Analytical QA Reviewer

Regulatory AI & Automation Specialist

Product Management Specialist

Senior GRA Labeling Specialist

Safety & PV Specialist I

QA Specialist

Corporate Legal (Senior Manager)

RA Senior Manager OH Category

Sr. Specialist - Regulatory Affairs - Operations 4D

Related jobs to explore

I want to receive the latest job alerts for regulatory affairs specialist in kukatpally hyderabad telangana

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected