Copmed Hiring R&D Documentation Research Associate

COPMED PHARMACEUTICALS PRIVATE LIMITED.; Dehradun; On-site; INR 600,000 - 900,000; Full time

Job summary

Copmed Research Centre in Dehradun invites an experienced Research Associate – R&D Documentation to join our regulated pharma team. The role focuses on preparing, reviewing and lifecycle-managing critical R&D and regulatory documents for APIs, raw materials and finished dosage forms.

Candidates should hold M.Pharm or MSc and have at least 3 years pharma R&D documentation experience, with hands-on regulatory coordination and ICH-compliant systems.

Qualifications

• M.Pharm or MSc in Pharmaceutical Sciences or related field
• Minimum 3 years pharma R&D documentation experience
• Experience with regulatory documentation and ICH-compliant systems
• Gender: Male (as specified by the employer)

Responsibilities

• Prepare and review API, raw material, and finished dosage form documentation.
• Prepare specs, STPs, and SOPs per ICH guidelines.
• Manage AMV, AMT, and pharmacopoeial updates.
• Coordinate regulatory responses and change controls.
• Ensure data integrity and audit readiness of R&D docs.
• Maintain document control systems and archival processes

Skills

Pharma documentation

Regulatory compliance

ICH guidelines

Data integrity

Education

M.Pharm

MSc

Tools

Document control systems

Job description

M.Pharm R&D Documentation Jobs | Copmed Dehradun

Copmed Research Centre hiring R&D Documentation Research Associate in Dehradun. M.Pharm, MSc eligible. 3+ years experience.

Copmed Research Centre, a dedicated research and development unit of Mankind Pharma, is hiring an experienced Research Associate – R&D Documentation for its advanced R&D facility located at Sara Industrial Area, Rampur, Selaqui, Dehradun. This opportunity is designed for professionals with strong exposure to pharmaceutical documentation, regulatory compliance, and ICH-guided R&D systems who want to work in a structured, innovation-driven research environment.

The role plays a critical part in ensuring regulatory-ready documentation across APIs, raw materials, and finished dosage formulations. Candidates with hands-on experience in pharma R&D documentation and regulatory coordination will find this position highly aligned with long-term growth in pharmaceutical research and compliance-driven development.

Company Overview

Copmed Research Centre operates as a specialized R&D unit under the Mankind Pharma group, one of India’s leading pharmaceutical companies with a strong domestic and international footprint. The research centre supports formulation development, regulatory documentation, and lifecycle management activities that contribute directly to the availability of safe, effective, and compliant pharmaceutical products.

Backed by Mankind Pharma’s industry credibility, Copmed Research Centre follows stringent ICH, pharmacopoeial, and regulatory standards. The facility at Selaqui, Dehradun, is equipped to handle complex documentation, development support, and regulatory readiness activities essential for modern pharmaceutical R&D operations.

Job Role & Responsibilities

Research Associate – R&D Documentation

The Research Associate will be responsible for preparation, review, and lifecycle management of critical R&D and regulatory documents supporting APIs, raw materials, and drug products.

Key responsibilities include:

• Preparation and review of specifications, STPs, and SOPs for API, raw materials, and finished dosage forms as per ICH guidelines
• Handling Analytical Method Validation (AMV), Analytical Method Transfer (AMT), and pharmacopoeial updates
• Managing formulation changes and associated documentation updates
• Preparation and review of analytical protocols, cleaning STPs, and test license documents
• Reviewing impurity justifications and conducting elemental impurity and nitrosamine risk assessments
• Managing document control systems, change control processes, and archival activities
• Coordinating responses for regulatory authority and agency queries
• Ensuring data integrity, compliance, and audit readiness of R&D documentation

This role is documentation-intensive and requires a strong understanding of regulatory expectations and pharmaceutical quality systems.

Eligibility / Qualifications

Educational Requirements

• M.Pharm
• M.Sc (Pharmaceutical Sciences, Chemistry, or related disciplines)

Relevant courses include: Pharmaceutical Analysis, Pharmaceutics, Regulatory Affairs, Pharmaceutical Chemistry, Analytical Chemistry, Industrial Pharmacy, Quality Assurance

Experience Criteria

• Minimum 3+ years of hands-on experience in Pharma R&D Documentation
• Prior exposure to regulatory documentation and ICH-compliant systems is mandatory

Additional Requirements

• Gender requirement: Male (as specified by the employer)
• Immediate joiners are preferred

Location & Salary

Work location: Sara Industrial Area, Rampur, Selaqui, Dehradun, Uttarakhand.

Compensation is performance-based and will depend on technical interview evaluation and current CTC. The salary structure is competitive for R&D documentation roles within regulated pharmaceutical environments.

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Why Build Your Career with Copmed Research Centre

Working at Copmed Research Centre offers exposure to high-quality pharmaceutical R&D documentation systems that directly support regulatory submissions and product lifecycle management. Professionals in this role contribute to healthcare advancement by ensuring compliance, data integrity, and regulatory readiness of pharmaceutical products developed under globally accepted standards.

FAQs

Who can apply for this position?

Candidates with M.Pharm or M.Sc qualifications and a minimum of 3 years of pharma R&D documentation experience can apply.

Is regulatory documentation experience mandatory?

Yes. Hands-on experience with ICH-compliant R&D documentation is mandatory for this role.

Are freshers eligible?

No. This role requires prior industry experience.

Is this role related to API or formulation documentation?

Yes. The role covers documentation for APIs, raw materials, and finished dosage formulations.

How can I apply?

You can apply by emailing your resume to the provided Copmed Research Centre email IDs.