Home
Jobs
Companies
Resume
Exemed logo

Reqd Regulatory Affairs - Sr Officer/Exe- Pharma API Business

3 - 5 years

3 - 5 Lacs

Vadodara

Posted:3 weeks ago| Platform: Naukri logo

Apply

Skills Required

Regulatory Guidelines New Drug Applications SND ICH USFDA APIs. CDSCO RA impurity profiling Characterization Regulatory Affairs Dossier EMA global regulatory guidelines API Chemistry Characterization Nitrosamine impurity assessment Interdepartmental Coordination

Work Mode

Work from Office

Job Type

Full Time

Job Description

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (both Open and Closed Parts) for submission to national and international regulatory authorities. Ensure data integrity and compliance with ICH and other global regulatory guidelines . Regulatory Documentation & Submissions: Prepare, review, and submit CDSCO-specific checklists for New Drug Applications (ND) and SND (Subsequent New Drug) filings for APIs. Regulatory Compliance: Stay current with evolving regulations and guidelines issued by CDSCO, ICH, USFDA, EMA , and other global regulatory bodies. Assist in audits and regulatory inspections by preparing and presenting required documentation. Liaison with Regulatory Authorities: Coordinate with Local FDA & CDSCO Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication. If interested please share updated resume on corporate.hr@exemedpharma.com

More Jobs at Exemed

Required MIS & Costing Executive/Senior Executive, Pharma Co.

Vadodara

4 - 6 yrs
|

INR 5 - 8 Lacs

Required Sr. CT QA-Auditor

Vadodara

2 - 5 yrs
|

INR 3 - 5 Lacs

Purchase Officer/Sr Officer- Pharma API Co.

Vadodara

Experience: Not specified

|

INR 1 - 3 Lacs

Required Manager/Sr Manager - API Marketing - Domestic Market

Vadodara, Mumbai (All Areas)

10 - 15 yrs
|

INR 12 - 20 Lacs

Required Executive/Sr Executive- International Marketing

Vadodara, Mumbai

3 - 8 yrs
|

INR 5 - 10 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Regulatory Guidelines Interview Now
Exemed
Exemed
www.exemed.com

Medical Education and Training

Castel Maggiore

51-200 Employees

12 Jobs

    Key People

  • Andrea Zamboni

    Chief Executive Officer

  • Alessandra Cacciola

    Business Development Manager

RecommendedJobs for You

Exemed logo

Reqd Regulatory Affairs - Sr Officer/Exe- Pharma API Business

Exemed

Vadodara

Hilti logo

Senior Manager - Product Regulatory Compliance

Hilti

Gurugram

Third Bridge logo

Compliance Associate, Content (UK Hours)

Third Bridge

Mumbai

Budgetcfs Terminals logo

Legal Officer - Male

Budgetcfs Terminals

Navi Mumbai

Augusta Infotech logo

Associate Director Managed Review - eDiscovery

Augusta Infotech

Bengaluru

Hocco Industries logo

Company Secretary

Hocco Industries

Bavla

Zeon Lifesciences logo

Regulatory Affairs Apprentice (Male)

Zeon Lifesciences

Noida

Digital Aptech logo

Manager - General Affairs & Legal

Digital Aptech

Kolkata

Neena Deshpande & Co logo

Semi Qualified CS and Management Trainees

Neena Deshpande & Co

Thane

Protiviti India logo

Legal Officer

Protiviti India

Bengaluru