Hyderabad Telangana Pharmaceutical regulatory affairs Jobs – 47 Open Jobs Today

Regulatory Affairs Labeling Specialist
Regeneron —Hyderabad, Telangana
- Microsoft Word
- Microsoft Office
- Analysis skills
- Health insurance
- Paid time off
7d
Specialist - Regulatory Affairs - Operations 4B
Genpact India Pvt. Ltd. —Hyderabad, Telangana
- Full-time
- Hybrid work
- English
- Master's degree
- Bachelor's degree
Quick apply
Sr. Associate Regulatory Affairs
Amgen —Hyderabad, Telangana
- B.Sc
- Project management
- Bachelor's degree
Senior Regulatory Affairs Specialist
Medtronic —Nanakramguda, Hyderabad, Telangana
- Full-time
- Bachelor's degree
- Communication skills
Clinical Research Coordinator
QED Pharmaceutical Services —Hyderabad, Telangana
- Medicine
- Doctoral degree
- Bachelor's degree
Regulatory Affairs Manager
Medtronic —Nanakramguda, Hyderabad, Telangana
- Full-time
- Engineering
- Analysis skills
- Bachelor's degree
Regulatory Labeling Mgr
Amgen —Hyderabad, Telangana
- Master's degree
- Analysis skills
- Bachelor's degree
Analytical QA Reviewer
DIFGEN PHARMACEUTICALS PRIVATE LIMITED —Kukatpally, Hyderabad, Telangana
- Full-time
- Analysis skills
- Quality control
- Manufacturing
Medical Science Liaison (East Zone) - Hyderabad
BI India —Hyderabad, Telangana
- Online application
- Microsoft Office
Research Associate
DIFGEN PHARMACEUTICALS PRIVATE LIMITED —Kukatpally, Hyderabad, Telangana
- Quality control
- Manufacturing
Director, Scientific and Operations Intelligence - Obesity
Amgen —Hyderabad, Telangana
- Master's degree
- Bachelor's degree
- In-person
Liasoning Officer
PathnSitu Biotechnologies Pvt Ltd —Hyderabad, Telangana
- ₹20,000 - ₹35,000 a month
- Full-time
- Microsoft Office
- Bachelor's degree
- Business Administration
Quick apply
Mrgr Corporate Communications
Regeneron —Hyderabad, Telangana
- English
- Project management
- Bachelor's degree
- Health insurance
- Paid time off
6d
Analyst
Granules India —Hyderabad, Telangana
- Master's degree
- APIs
Sr Scientist I/ Sr. Scientist II, Documentary Standards (Excipients)
The U.S. Pharmacopeia (USP) —Hyderabad, Telangana
- Full-time
- Doctoral degree
- English
- Master's degree
- Paid time off
- Flexible schedule
Manager Corporate Affairs
Amgen —Hyderabad, Telangana
- Microsoft Powerpoint
- Master's degree
- Project management
Senior Research Associate
DIFGEN PHARMACEUTICALS PRIVATE LIMITED —Kukatpally, Hyderabad, Telangana
- Full-time
- Quality control
- Organisational skills
- Manufacturing
Research Scientist - Tech Transfer
DIFGEN PHARMACEUTICALS PRIVATE LIMITED —Kukatpally, Hyderabad, Telangana
- Bachelor's degree
- Continuous improvement
- Quality control
QA Specialist
AVEVA DRUG DELIVERY SYSTEMS INC —Kukatpally, Hyderabad, Telangana
- ₹30 - ₹40 an hour
- Analysis skills
- Bachelor's degree
- Travel
Associate Manager Medical Supply Operations
Sanofi —Hyderabad, Telangana
- English
- Microsoft Office
- Administrative experience
13d

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Regulatory Affairs Labeling Specialist

Regeneron -
Hyderabad, Telangana

Apply Now

Job details

7 days 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

pharmaceutical regulatory affairs jobs in hyderabad telangana

Regulatory Affairs Labeling Specialist

Specialist - Regulatory Affairs - Operations 4B

Sr. Associate Regulatory Affairs

Senior Regulatory Affairs Specialist

Clinical Research Coordinator

Regulatory Affairs Manager

Regulatory Labeling Mgr

Analytical QA Reviewer

Medical Science Liaison (East Zone) - Hyderabad

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Director, Scientific and Operations Intelligence - Obesity

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Sr Scientist I/ Sr. Scientist II, Documentary Standards (Excipients)

Manager Corporate Affairs

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Associate Manager Medical Supply Operations

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