hireejobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Manager Regulatory Affairs

Fresher   Haryana   28 Oct, 2025
DDReg Pharma
Job LocationHaryana
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaNot Mentioned
EmploymentTypeFull-time

Job Description

    As a Regulatory Affairs professional in our company, you will play a crucial role in ensuring compliance with regulatory guidelines and maintaining the highest quality standards in the technical documentation for regulatory filings. Your responsibilities will include:- Conducting CMC review of technical documentation for regulatory filings to various markets, with a focus on the US market- Performing Gap Analysis and Remediation for module 3 -CMC- Developing and implementing regulatory strategies, processes, and timelines for grant of MA in regions like Africas, GCC, LATAM, ASEAN- Reviewing CTD dossiers, variations, change controls, renewals to ensure compliance with regulatory guidelines- Ensuring internal consistency, adherence to relevant guidelines, and promoting regulatory excellence in documentation for submission- Demonstrating expertise in subject matter and regulatory knowledge- Collaborating with internal and external clients for effective communication and operational excellenceTo excel in this role, you should possess:- A Masters degree in Pharma- 7 to 10 years of relevant experience or equivalent combination of education and training- Excellent technical data interpretation and interpersonal skills- Strong oral and written communication skills with proficiency in presentations- Significant knowledge of US Regulations- Proficiency in document management systems, Microsoft Word, PowerPoint, Excel- Ability to work in a team-oriented environment and deliver quality outputs within tight timelinesAdditionally, you should be flexible, adaptive, and capable of working under pressure. As part of the job requirements, you may need to accommodate working slots catering to different time zones.Join us in Gurgaon, Haryana (INDIA) and be a part of our team dedicated to regulatory affairs in the pharmaceutical industry.,

Keyskills :
Regulatory AffairsTechnical DocumentationGap AnalysisRemediationRenewalsQuality StandardsInterpersonal SkillsProblem SolvingCommunication SkillsMicrosoft WordPowerPointExcelRegulatory StrategiesCTD DossiersChange ControlsCountry Regulations

APPLY NOW

Manager Regulatory Affairs Related Jobs

© 2019 Hireejobs All Rights Reserved