Regulatory Affairs Executive Job Vacancies in Mumbai

Urgent OpeningIn a Veterinary Pharmaceutical CompanyLocation: Vile Parle East, Mumbai, MaharashtraSalary: 4 LPA to 5 LPAExperience: 5 to 6 YearsGender: Both Should have good knowledge of preparing Dossier of Drugs & Feed Supplements in different countries Managing regulatory affairs of the organization & its subsidiaries / associates. Liaising with regulatory bodies like State and Central FDA, DCI, etc. Well conversant with Drug law/feed supplement regulation. Compilation and preparation of tender documents. Coordinating documents & process for Audit. FDA Documentation & Portal handling. FSC, legal action and other statutory document perpetration and compilation.

Job description1. Ensuring preparing & submission of Dossiers for Product registration for local and export.2. Ensure accuracy, completeness and quality of regulatory submissions.3. Handling local FDA, DCGI requirements.4. Ensure that all product artwork is updated when necessary and submitted in correct format and that subsequent approved artwork is accurately recorded and communicated.5. Ensuring accurate recording and communication of regulatory submissions, correspondence with authorities and final approval to facilitate compliance.6. Ensuring accurate and timely responses to queries from internal and external customers.7. Carrying out any task delegated by Export Manager which contributes to overall running of the Export Department and assisting Export Manager in marketing & business development activities.8. Participate in training activities for career development to attain a high level of competency in all aspects of regulatory affairs.Candidate Specifications:-- Minimum 2 years of experience in regulatory affairs from pharmaceutical formulation background.- Should have a strong command over written & verbal communication in English.- Should be a permanent resident from Mumbai & have accommodation here.- Good knowledge of ICH, WHO, and regulated marketSalary - 4.00 to 5.50 lakhs p.a