Job Title: Regulatory Affairs Specialist
Company: [Company Name]
Location: Nagpur, Kalameshwar
Employment Type: Full-time
Experience: 3-6 years
Department: Regulatory Affairs
Job Responsibilities:
- Preparation, Review, and Planning: Prepare, review, and plan the submission of Common Technical Document (CTD), ASEAN Common Technical Document (ACTD), or Electronic Common Technical Document (ECTD) for export markets.
- Communication: Float official emails for technical documents and queries reply, ensuring effective communication channels.
- Site Registration: Prepare and monitor site registration documents for export markets, ensuring compliance with regulatory requirements.
- Regulatory Submissions: Handle registration, re-registration, and post-approval changes applications for export markets, ensuring timely submission.
- Technical Query Resolution: Resolve technical queries related to product registration, re-registration, and post-approval changes efficiently.
- Internal Coordination: Coordinate with internal stakeholders including Quality Assurance (QA), Quality Control (QC), Research & Development (R&D), Technical Services, Production, Packing, Accounts, Purchase, and Business Development departments.
- Document Review: Review technical documents, including process validation, stability data, analytical method validation, product development reports, specifications, batch records, and certificates of analysis, ensuring compliance with regulatory standards.
- Bioequivalence (BE) Studies: Intimate and review BE studies from approved BE centers, ensuring adherence to regulatory requirements.
- Manufacturing Coordination: Follow up with manufacturing sites for registered samples, working standards, and impurity requirements for lab analysis.
- Reporting: Prepare monthly regulatory status reports and maintain the status of new registrations, re-registrations, and post-approval changes.
- Dossier Preparation: Coordinate with stakeholders for document collection, dossier preparation, review, and submission to regulatory authorities.
- Artwork Review: Review artwork and pack inserts according to rules laid by respective regulatory authorities.
- Product Safety: Prepare and submit Product Safety Update Reports as required.
- License Renewal: Coordinate the renewal of FDA licenses including Good Manufacturing Practice (GMP), Certificate of Pharmaceutical Product (COPP), manufacturing licenses, and wholesale licenses.
Qualifications:
- B.Pharm, M.Pharm, Msc, Bsc, Lifesciences
- 3-6 years of experience in regulatory affairs within the pharmaceutical industry.
- Familiarity with CTD/ACTD/ECTD submissions for export markets.
- Strong communication and coordination skills.
- Knowledge of regulatory requirements and guidelines.
- Ability to work effectively in a cross-functional team environment.