22 Job openings found

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 ...

Job Location : Mahape, Nearest Station Ghansoli (Navi Mumbai)   Look for people from Navi Mumbai or Mumbai Only   Only Female Candidates required   Qualification : B.Pharm / M.pharm   Experience : 1yr – 3yr   Salary : 1.42lpa – 2 .80lpa     Profile : Experience in preparing Dossiers in CTD, ACTD, Country Specific Dossiers.   Countries : ROW and Latum   Job Description: Dossier Preparation along ...

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 ...

Job Description   -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US) -Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report. -Have ability to co-ordinate with ...

Job responsibilities are to Assist Regulatory manager: Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, CIS To manage ...

Job responsibilities : Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, CIS To manage new registration / preregistration ...

Job Description:  Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. ? Preparation, Compilation & Review of Registration documents that include Administrative & Technical. ? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ...

Position:         Asst. Manager/ Manager - ADL Location:         Vapi Experience:      8 - 10 Years Industries:       Pharma - API  Responsibilities: Analytical Development & Validation   Lead development, optimization, and validation of analytical methods for APIs, intermediates, and finished dosage forms. Perform method validation as per ICH, USP, EP, and IP ...