12 Job openings found

Job Title: R&D Executive – Dossier / Regulatory Affairs No. of Positions: 3Company: Concept PharmaLocation: AurangabadCTC: ₹NegotiableExperience:  1–2 YearsQualification: 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 ...

Position:         RA Executive (Khopoli) Location:        Khopoli - Raigarh Experience:     5 - 6 Years Industries:      Pharma    Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and ...

  Key Responsibilities: Prepare, compile, and submit CTD/eCTD dossiers for EMA and DGMED (France) including new registrations, renewals, and variations. Coordinate with internal teams (QA, QC, R&D, Supply Chain) for document collection and compliance. Liaise with regulatory agencies and local representatives in the EU and France for query resolution and approvals. Ensure dossiers and product ...

works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions ...

    Regulatory Affairs Officer (RA) Qualification: B.Pharm/ M.Pharm Experience: Minimum 3 years in regulatory affairs for the ROW (Rest of the World) market, with a total of 3 to 5 years of experience. Job Description: Preparing dossiers as per country-specific guidelines. Compiling and reviewing documents. Coordinating with QA for documentation. Addressing queries raised by respective countries' FDA. Bond: 18-month ...

works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions ...

Job description for API Regulatory: Preparation, review and submission of Drug Master Files/CEP in eCTD format for the regions US, EU through ESG and CESP. Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates). Preparation, review and submission of Applicant's Part DMF (Open Part DMF) and Technical data ...

Job Description – Regulatory Affairs Specialist Company: Concept Pharma Pvt. Ltd. Position: Regulatory Affairs Specialist Vacancies: 2 Experience: 5–10 Years CTC (Budget): Negotiable Location: Aurangabad Key Responsibilities Lead and manage the compilation, preparation, and submission of regulatory dossiers for domestic and international markets in ACTD/CTD formats. Ensure full compliance with CDSCO regulations and global regulatory requirements ...

Position:         RA Trainee(Khopoli) Location:        Khopoli - Raigarh Experience:     0 - 1 Years Industries:      Pharma    Responsibilities: Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets. Support the collection and review of technical documents from R&D, QA, QC, and Production ...

DMF API Submission experience is must Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements. Preparation of Applicant part of DMF for Brazil, US, and ROW market. Preparation of all administrative statements for respective authority requirements. Drafting of regulatory response for ...