Job Description

Job Title: R&D Executive - Dossier / Regulatory Affairs
No. of Positions: 3
Company: Concept Pharma
Location: Aurangabad
CTC: ₹Negotiable
Experience: 1-2 Years
Qualification: B.Pharm / M.Pharm
Job Summary
Concept Pharma is seeking R&D Executives (Dossier / Regulatory Affairs) to support preparation, compilation, and submission of regulatory dossiers for pharmaceutical products. The role is suitable for freshers as well as candidates with up to 1-2 years of experience who are looking to build a career in pharmaceutical R&D and regulatory documentation.
Key Responsibilities
Prepare, compile, and review regulatory dossiers (CTD / eCTD) for domestic markets.
Assist in documentation related to product development, technology transfer, and regulatory submissions.
Coordinate with R&D, QA, QC, and Production teams for required technical data and documents.
Support preparation of DMF, ANDA, and other regulatory documents as applicable.
Maintain and update regulatory databases, submission trackers, and document control systems.
Assist in responding to regulatory queries, deficiencies, and review comments.
Ensure documentation complies with current regulatory guidelines and company SOPs.
Support audits, inspections, and regulatory assessments when required.
Required Qualifications & Skills
B.Pharm / M.Pharm (Pharmaceutics, Quality Assurance, or related specialization preferred).
Fresher or 1-2 years of experience in R&D documentation or Regulatory Affairs.
Basic knowledge of CTD / eCTD structure and regulatory requirements.
Good understanding of pharmaceutical documentation practices.
Proficiency in MS Office (Word, Excel, PowerPoint).
Strong attention to detail and good organizational skills.
Good communication and coordination abilities.
Preferred Candidate Profile
Candidates with exposure to dossier preparation or regulatory submissions will be preferred.
Freshers with strong academic knowledge and interest in regulatory affairs are encouraged to apply.
Ability to manage multiple documents and meet submission timelines.

Skills Required