Hyderabad Telangana Regulatory affairs Jobs – 27 Open Jobs Today

Research Associate
DIFGEN PHARMACEUTICALS PRIVATE LIMITED —Kukatpally, Hyderabad, Telangana
- ₹5 - ₹8 a year
- Full-time
- Master's degree
- Project management
- APIs
GRA Labelling Group Lead
Sanofi —Hyderabad, Telangana
- Management
- English
- Analysis skills
- Paid sick time
13d
HR Executive
FORWARD LIFE PVT.LTD —Ameerpet, Hyderabad, Telangana
- ₹18,000 - ₹22,000 a month
- Full-time
- Microsoft Word
- Microsoft Excel
- Master's degree
- Health insurance
Quick apply
3d
Team Lead GRA Labeling Strategist Transversal
Sanofi —Hyderabad, Telangana
- Management
- English
- Analysis skills
13d
Deputy Manager/Manager
Azurity Pharmaceuticals - India —Hyderabad, Telangana
- English
- Master's degree
- Communication skills
Quick apply
Chief Executive Secretary
FORWARD LIFE PVT.LTD —Ameerpet, Hyderabad, Telangana
- ₹18,000 - ₹25,000 a month
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Health insurance
Quick apply
RA Senior Manager OH Category
Haleon —Hyderabad, Telangana
- Full-time
- Agile
- Communication skills

More jobs to discover

Find similar jobs that you might be interested in.

GRA Labelling Group Lead
Sanofi —Hyderabad, Telangana
Very strong ability to lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal,…
13d
Team Lead GRA Labeling Strategist Transversal
Sanofi —Hyderabad, Telangana
Strong ability to lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal,…
13d

I want to receive the latest job alerts for regulatory affairs in 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 jobs near hyderabad telangana

Deputy Manager jobs in Hyderabad, Telangana

Labeler jobs in Makarba, Ahmedabad, Gujarat

Research Associate jobs in Noida, Uttar Pradesh

Research Associate jobs in Kochi, Kerala

Research Associate jobs in Jammu And Kashmir

Physics Research jobs in Mumbai, Maharashtra

Clinical Research jobs in Gujarat

Annotation, Data Associate jobs in Kerala

Research Associate jobs in Chandigarh, Chandigarh

Prestige Group, Bengaluru jobs in Bengaluru, Karnataka

Group Leader jobs in Gummidipoondi, Chennai, Tamil Nadu

Group Leader jobs in Udaipur, Rajasthan

The Prestige Group jobs in Bengaluru, Karnataka

Sanjay Rungta Group Of Institutions,bhilai 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

Senior Category Manager jobs in Bengaluru, Karnataka

Operations Manager jobs in Gurgaon Sector 45, Gurugram, Haryana

Research Associate

DIFGEN PHARMACEUTICALS PRIVATE LIMITED -
Kukatpally, Hyderabad, Telangana

Apply Now

Job details

Full-time
₹5 - ₹8 a year

Qualifications

Master's degree
Project management
APIs

Full job description

Role Definition:

The Research Associate(RA) Regulatory Affairs (RA) is responsible for the strategic and operational aspects of regulatory, review, compilation, submissions, approvals, and compliance across multiple markets (i.e. USA, EU, Canada etc. but not limited to these). This role ensures timely submissions of quality applications ,approvals, robust regulatory knowledge, and adherence to global regulatory standards. The SRA also supports cross-functional business objectives.

2. Key Responsibilities:

2.1 Regulatory Strategy & Dossier Management:

2.1.1 Should have prior 3-5 years submissions experience, including new product approvals, PLCM/Supplements/ variations, Annual reports/renewals, and amendments across Global markets with competent Global Regulatory Authorities (i.e. U.S. FDA, EMA, Health Canada etc.) for Complex Solid Oral Dosage forms and Injectables.

2.1.2 Ensure all submissions meet country-specific regulatory requirements and internal quality standards.

2.1.3 Support regulatory guidance to cross-functional teams (R&D, Quality, Project Management, Purchase Team, CMO, API Vendor etc.) for product lifecycle management.

2.1.4 Track and resolve regulatory authority deficiencies to avoid delays in approvals.

2.1.5 Maintain and monitor approval timelines to ensure regulatory compliance and business continuity.

2.2 Regulatory Intelligence & Compliance :

2.2.1 Monitor and keep updated over the global regulatory changes and evolving regulatory requirements/or expectations and provide strategic recommendations to ensure to remain in compliance.

2.4 Regulatory Data & Documentation Management:

2.4.1 Ensure that all regulatory documents, submissions, and correspondence are archived in time periodically in an organized, traceable manner.

2.4.2 Maintain integrity, traceability, and accuracy of regulatory databases and electronic records of ANDA/MAA/DCP/MRP/CP/ANDS/IND etc, but not limited to these .

2.4.3 Collaborate with internal stakeholders/cross functional team to support strategy, compliance, and operational excellence.

Position:

Role: Research Associate-Global Regulatory Affairs

Industry Type: Pharmaceutical

Education

PG: M.Pharm, in Pharmaceuitics /or Regulatory Affairs

Any additional degree is preferred.

Key Skills

Regulatory Affairs

Experience: Minimum 3-5 Years of Experience in regulatory affairs with OSD/Parenteral including conventional as well as complex dosage forms in generic space (ANDA/MAA/ANDS) and/or NDA/505(b)(2).

Education

PG: M.Pharm, in Pharmaceuitics /or Regulatory Affairs

Any additional degree is preferred.

Key Skills

Regulatory Affairs

Experience: Minimum 3-5 Years of Experience in regulatory affairs with OSD/Parenteral including conventional as well as complex dosage forms in generic space (ANDA/MAA/ANDS) and/or NDA/505(b)(2).

Apply Now

Refine Your Search

regulatory affairs jobs in hyderabad telangana

Research Associate

GRA Labelling Group Lead

HR Executive

Team Lead GRA Labeling Strategist Transversal

Deputy Manager/Manager

Chief Executive Secretary

RA Senior Manager OH Category

More jobs to discover

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

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected