Regulatory Affairs
19 hours ago
Company Description
Clinforge Clinical Research Solutions Pvt. Ltd. is an emerging
Contract Research Organization (CRO)
dedicated to advancing excellence in
scientific writing, regulatory documentation, and clinical research support services.
Headquartered in Lucknow, India, Clinforge operates at the intersection of
education, research, and regulatory compliance
, serving as a bridge between academic innovation and industry implementation. With a focus on quality, ethics, and precision, Clinforge provides customized solutions to pharmaceutical, biotechnology, and academic partners seeking expertise in
medical and scientific communication, clinical data documentation, and regulatory submissions.
We suggest you enter details here.
Role Description
Regulatory Documentation Standards
· Align all medical/scientific writing with
ICMJE, GPP3, and ICH E6 (R2)
.
· Create internal SOPs for Manuscript Writing, Literature Review, and Publication Ethics.
· Set up templates for CSR, IB, and CTD documentation (for future regulatory writing projects).
·
Publication & Compliance Oversight
· Ensure Clinforge's
Journal of Drug Development & Clinical Research (JDDCR)
follows COPE guidelines.
· Support ISSN registration, peer-review documentation, and indexing compliance.
·
Institutional Ethics & Audit Readiness
· Prepare Clinforge for future CRO licensing by documenting SOPs and quality standards.
· Liaise with consultants for registration under CDSCO / Institutional Bioethics Committee in future phase.
AICTE/PCI/UGC Alignment
· Study guidelines for
Skill Development Courses
,
Value-Added Programs
, and
Vocational Education
.
· Draft frameworks for credit-based certification courses as per
AICTE Model Curriculum for Pharmacy Education
.
· Prepare documents for MoUs, add-on courses, and short-term program approvals.
·
NAAC Compliance
· Design documentation templates for colleges (Attendance, Feedback, Outcome Mapping).
· Create a "CPA Compliance Handbook" that partner colleges can use during NAAC visits.
· Map each CPA course with
Learning Outcomes
required under NAAC/NBA.
Qualifications
- Experience in Regulatory Documentation and Dossier Preparation
- In-depth understanding of Regulatory Requirements and Regulatory Compliance
- Proven experience in Regulatory Affairs
- Excellent written and verbal communication skills
- Detail-oriented and highly organized
- Ability to work independently and collaboratively
- Advanced degree in a relevant field (e.g., life sciences, pharmacy, law) is a plus
- Experience in the healthcare or pharmaceutical industry
-
Drug Regulatory Affairs Officer
1 week ago
Lucknow, Uttar Pradesh, India Lucent Biotech Full time ₹ 12,00,000 - ₹ 24,00,000 per yearPreparation, review, and submission of CTD/eCTD/ACTD dossiers, ensuring compliance with ICH, WHO, ASEAN, and country-specific regulatory requirements.
-
Director
2 days ago
Lucknow, Uttar Pradesh, India Babu Banarasi Das Institute of Technology & Management Full time ₹ 20,00,000 - ₹ 25,00,000 per yearPreferred candidate profilePh.D. in a relevant field, along with a minimum of 15 years of experience with at least 3 years at the level of Professor. Strong academic credentials, including research publications and experience guiding doctoral studentsRole & responsibilitiesProvide academic leadership and maintain educational standardsOversee faculty...
-
PMT ( Product Management Trainer)
4 days ago
Lucknow, Uttar Pradesh, India 3e7e326c-56a0-4315-bed0-02e35cd47726 Full time ₹ 20,000 - ₹ 35,000 per yearJob Title: PMT (Product Management Trainer ) Location: Field work with Marketing Team Experience: 4 to 5 Years We are looking for a dynamic professional to join our Product Management Team (PMT) responsible for end-to-end brand and product lifecycle management within the pharmaceutical domain. Key Responsibilities Develop and implement marketing strategies &...
-
GM/ Legal
6 days ago
Lucknow, Uttar Pradesh, India HR World Solutions Full time ₹ 5,00,000 - ₹ 25,00,000 per yearJob Title: GM/Sr.GM LegalDepartment: LegalReporting To: DirectorLocation: LucknowFemale will be preferredQualifications & Skills:Bachelors degree in Law (LLB) is a must; Master's in Law (LLM) is an advantage or CS will give weightage.15–25 years of relevant experience in legal domain, preferably in real estate or construction industry.In-depth knowledge of...
-
RMA (RD) - Lucknow (AP)
12 hours ago
Lucknow, Uttar Pradesh, India Domnic Lewis Pvt. Ltd Full time US$ 10,000 - US$ 50,000 per yearRegional Medical Advisor (RD) - LucknowDomnic Lewis has been mandated to hire for Regional Medical Advisor (RD) - LucknowThe Field-Based Scientific Expert (FSE) plays a critical role in executing the Medical Affairs Plan(s) for pre-launch and newly launched products or indications. The role focuses on shaping clinical practice through scientific engagements,...
-
Drug Regulatory Affairs Executive
2 weeks ago
Lucknow, India Lucent Biotech Ltd. Full timeLucent Biotech Limited company Hiring For **Drug Regulatory Affairs Executive.** **Regulatory affairs officers ensure the appropriate licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy** As a regulatory affairs officer you'll be the crucial link between your company, its...
-
Drug Regulatory Affairs
2 days ago
Lucknow, India Lucent Biotech Ltd. Full time**ob description** **DRA Executive** Job Description: - Preparation and review of Dossiers and related Documents for Product Registrations as per the CTD, ACTD, eCTD, and National Guidelines. Responsible for the complete process from Receiving of the Product until the Registration in the Specific Country - Handing of FDA Queries, Reviewing and Updating...
-
Student Legal and Compliance Manager
2 weeks ago
Lucknow, India The Language SKOOL Full timePosition Title: Student Legal and Compliance ManagerDepartment: Legal & Compliance / Student AffairsLocation: RemoteEmployment Type: Full-timePosition OverviewThe Student Legal and Compliance Manager is responsible for ensuring that the institution’s student-related policies, procedures, and operations comply with all applicable laws, regulations,...
-
Student Legal and Compliance Manager
2 weeks ago
Lucknow, India The Language SKOOL Full timePosition Title: Student Legal and Compliance ManagerDepartment: Legal & Compliance / Student AffairsLocation: RemoteEmployment Type: Full-timePosition OverviewThe Student Legal and Compliance Manager is responsible for ensuring that the institution’s student-related policies, procedures, and operations comply with all applicable laws, regulations,...
-
Solution Consultant
3 weeks ago
Lucknow, India Matrix One Full timeSolution Consultant – India (Remote with Occasional Travel)Matrix One is a leading provider of software solutions for medical device companies, helping them manage regulatory and quality compliance with ease. Our mission is to streamline product development and compliance, enabling companies to bring medical devices to market faster and more...
-
Business Excellence Associate
2 weeks ago
Lucknow, India The House Of DoBe Full timeKey Responsibilities: Financial Operations & Oversight Maintain and monitor day-to-day accounting operations (bookkeeping, reconciliation, ledgers). Account reconciliations, vendor payments, and documentation. Support end-to-end P&L tracking, including budget vs. actual reporting, variance analysis, and financial forecasting. Maintain physical records in a...
-
Legal Officer
2 weeks ago
Lucknow, Uttar Pradesh, India Khushbu Auto Finance Limited Full time**Job Title**: Legal Officer **Location**: Lucknow, U.P **Company Name**:Khushbu Auto Finance Ltd.** **Company Overview**: **Khushbu Auto Finance Ltd.** is a fast-growing Non-Banking Financial Company (NBFC) that offers financial solutions for two-wheelers, three-wheelers, and other asset-backed financing. We focus on customer satisfaction, ethical lending...
-
Field Training Manager
2 days ago
Lucknow, Uttar Pradesh, India Bayer Full timeAt Bayer we re visionaries driven to solve the world s toughest challenges and striving for a world where Health for all Hunger for none is no longer a dream but a real possibility We re doing it with energy curiosity and sheer dedication always learning from unique perspectives of those around us expanding our thinking growing our capabilities and...