
Regulatory Affairs Officer
4 days ago
Assist in the preparation and review of regulatory dossiers in CTD/eCTD format for submission.
- Support in the compilation of documentation for New Marketing Authorizations, Post-Approval Variations, and Renewals.
- Coordinate with departments such as QA, QC, Production, R&D, and Packaging for data collation and timely submission.
- Review and verify product labeling, SmPCs (Summary of Product Characteristics) and artworks as per MHRA requirements.
- Track and manage regulatory submission timelines and maintain regulatory submission records.
- Assist in compiling response packages for deficiency letters / queries from MHRA.
- Support audits and inspections by MHRA by providing required regulatory documentation.
- Maintain awareness of changes in regulatory guidelines and communicate updates internally.
**Job Types**: Full-time, Permanent
Pay: ₹400,000.00 - ₹600,000.00 per year
Schedule:
- Day shift
Work Location: In person
-
Executive Officer Drug Regulatory Affairs
1 week ago
Panchkula, India Venus Remedies Full timeExecutive Officer Drug Regulatory Affairs (DRA) Job Posting: 11/27/2024 Panchkula JOB REQUIREMENTS Mandatory Qualifications Work Experience in Relevant Field 2.5-5 Years Technical Skills Required Who You'll Work With Regulatory Authorities What You'll Do Registration of new pharmaceutical drug Product.Renewal of approval of existing drug products....
-
Regulatory Affairs Officer
1 week ago
Panchkula, India Tiruvision Medicare Full time**Main Task**: - Studying scientific and legal documents - Gathering, evaluating, organizing, managing and collating information in a variety of formats - Ensuring compliance with regulations set by the Medicines and Healthcare Products Regulatory Agency (MHRA) - Maintaining familiarity with company product ranges - Planning, undertaking and overseeing...
-
Manager Drug Regulatory Affairs
1 day ago
Panchkula, Haryana, India Venus Remedies (VRL) Full time ₹ 4,00,000 - ₹ 8,00,000 per yearRole & responsibilitiesRegulatory Strategy Development:Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc.Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these...
-
Regulatory Affairs Executive
6 days ago
Panchkula, India jak pro solutions Full time**Key Responsibilities**: Prepare and compile documents for FDA approval, COA, MSDS and other regulatory submissions in line with updated industry standards and guidelines. Prepare, update, and maintain Batch Processing Reports (BPRs) as per regulatory and internal quality protocols. Verify product labels, packaging, and design for conformity with Legal...
-
Assistant Manager Regulatory Affairs
3 days ago
Panchkula, Haryana, India Venus Remedies (VRL) Full time ₹ 9,00,000 - ₹ 12,00,000 per yearRole & responsibilitiesRegulatory Submissions and Approvals:Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements.Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for...
-
Chief Export Officer
2 days ago
Panchkula, Haryana, India Venus Remedies Ltd Full time ₹ 1,04,000 - ₹ 1,30,878 per yearChief Export Officer - International BusinessThe Chief Exports Officer (CXO) will be entrusted with the strategic and operational command of Venus international commercial business with a primary focus on driving tangible sales and PL ownership. This pivotal role is central to achieving our ambitious global growth targets, not just by identifying...
-
Senior Regulatory Professional
2 days ago
Panchkula, Haryana, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000About This RoleWe are looking for a skilled professional to join our consulting team as a Senior Analyst.This is an excellent opportunity for someone with experience in regulatory and commercial power sector, especially in relation to power distribution utilities.The ideal candidate will have a strong technical foundation and the ability to prepare and file...
-
Chief Export Officer
15 hours ago
Panchkula, Haryana, India Venus Remedies Limited Full timeChief Exports Officer (International Business) Job Description: Chief Exports Officer Reports To: International Business Leadership Team Leadership: All International Business teams We are a distinguished, mid-sized Indian pharmaceutical leader, financially robust with revenues of approximately 700 crores and a dedicated team of 1400+ professionals. We are...
-
Chief Export Officer
2 days ago
Panchkula, Haryana, India Venus Remedies Limited Full time ₹ 4,00,000 - ₹ 8,00,000 per yearPosition Title: Chief Exports Officer (International Business)Job Description: Chief Exports OfficerLocation: Chandigarh/Panchkula | IndiaReports To: International Business LeadershipTeam Leadership: All International Business teamsOur Company:We are a distinguished, mid-sized Indian pharmaceutical leader, financially robust with revenues of approximately...
-
Chief Export Officer
2 days ago
Panchkula, India Venus Remedies Full timeChief Export Officer - International Business The Chief Exports Officer (CXO) will be entrusted with the strategic and operational command of Venus international commercial business with a primary focus on driving tangible sales and PL ownership. This pivotal role is central to achieving our ambitious global growth targets, not just by identifying...