Regulatory Affairs

21 hours ago

Lucknow, Uttar Pradesh, India Clinforge Clinical Research Solutions Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 18,00,000 per year

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 year

    Preparation, review, and submission of CTD/eCTD/ACTD dossiers, ensuring compliance with ICH, WHO, ASEAN, and country-specific regulatory requirements.

  • Director

    3 days ago

    Lucknow, Uttar Pradesh, India Babu Banarasi Das Institute of Technology & Management Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Preferred 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...

  • GM/ Legal

    5 days ago

    Lucknow, Uttar Pradesh, India HR World Solutions Full time ₹ 5,00,000 - ₹ 25,00,000 per year

    Job 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)

    13 hours ago

    Lucknow, Uttar Pradesh, India Domnic Lewis Pvt. Ltd Full time US$ 10,000 - US$ 50,000 per year

    Regional 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

    3 days ago

    Lucknow, Uttar Pradesh, India Lucent Biotech Ltd. Full time

    Lucent 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...

  • Officer - Regulatory Affairs

    1 week ago

    Lucknow, Uttar Pradesh, India Geetank Pharmaceutical pvt ltd Full time

    Geetank Pharmaceutical Pvt. Ltd. URGENT REQUIREMENT MALE CANDIDATE. POST- OFFICER REGULATORY AFFAIRS RESPONSIBILITIES- 1.DOSSIER 2.REVIEW 3.QUERY SOLVED QUALIFICATION- B PHARMA EXPERIENCE - MIN 02 YEAR (QA, RA ) SALARY - 12 K TO 16 K OFFICE TIME -10:00AM TO 6:00 PM INTERVIEW TIME- 11:00 AM TO 5:00PM CALLING TIME -10:00AM TO 6:00PM PRIYANKA...

  • Agm - Regulatory Affairs & Nodal

    1 day ago

    Lucknow, Uttar Pradesh, India Vodafone Idea Full time

    Job Req ID: 44289- Location: Lucknow, IN- Function: Other- About: - Vodafone Idea Limited is an Aditya Birla Group and Vodafone Group partnership. It is India’s leading telecom service provider. The Company provides pan India Voice and Data services across 2G, 3G and 4G platform. With the large spectrum portfolio to support the growing demand for data and...

  • Manager - Regulatory Affairs

    4 weeks ago

    Lucknow, Uttar Pradesh, India GENPACT Full time

    Ready to build the future with AI At Genpact we don t just keep up with technology we set the pace AI and digital innovation are redefining industries and we re leading the charge Genpact s AI Gigafactory our industry-first accelerator is an example of how we re scaling advanced technology solutions to help global enterprises work smarter grow faster and...

  • ▷ (Urgent Search) Lead Consultant - Regulatory Affairs

    4 weeks ago

    Lucknow, Uttar Pradesh, India GENPACT Full time

    Ready to build the future with AI At Genpact we don t just keep up with technology we set the pace AI and digital innovation are redefining industries and we re leading the charge Genpact s AI Gigafactory our industry-first accelerator is an example of how we re scaling advanced technology solutions to help global enterprises work smarter grow faster and...

  • Drug Regulatory Affairs

    1 week 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...

  • Solution Consultant

    2 days ago

    Lucknow, India Matrix One Full time

    Solution 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...

  • Sales & Marketing Executive

    1 week ago

    Lucknow, India RML Mehrotra Pathology Full time

    As the Marketing Executive, you will be **responsible for developing and executing marketing strategies tailored to our medical products and services**. Your deep knowledge of the medical field, coupled with your marketing expertise, will play a pivotal role in expanding our reach and impact. **Key Responsibilities**: **Strategic Planning**:Develop and...

  • Company Secretary

    1 week ago

    Industria Area Chinhat, Lucknow, Uttar Pradesh, India Concord Control Systems Limited Full time

    **Job Summary**: - **Key Responsibilities**: - **Governance and Compliance**: - Ensure the company adheres to all statutory and regulatory requirements. - Manage all aspects of corporate governance, including the preparation and filing of annual returns and other compliance-related documents. - Maintain statutory books, including registers of members,...

  • Rma (Rd) - Lucknow (Ap)

    3 days ago

    Lucknow, Uttar Pradesh, India Domnic Lewis Pvt. Ltd Full time

    **Regional Medical Advisor (RD) - Lucknow**: **Domnic Lewis has been mandated to hire for Regional Medical Advisor (RD) - Lucknow** The 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...