Hemmo Pharmaceuticals Private limited Recruitment September 2020.US FDA approved company that manufactures peptide APIs like Desmopressin, Leuprolide, Calcitonin, Buserelin and many others. We are a team of 180+ professionals with high degree of commitment and believe that talent and technology are our strengths.
Important Vacancy details:
- Post Name: Regulatory Affairs Officer/Executive
- Qualification: (UG – B.Sc – Chemistry) AND (PG- M.Sc – Chemistry)
- Experienced:4 to 6 years
- Location:Navi Mumbai
- Salary :₹ 4,00,000 – 5,00,000 P.A.
- Openings :01
- Contact:Mrs.Sneha Chavan/ 9321622308
Job Description: We have requirement for the post of Regulatory Affairs Officer/Executive in Hemmo Pharmaceuticals Private limited !
1. Compilation and Filing of DMF in CTD format for US, Europe, Canada and other countries as per requirement.
2. Responsible for DMF , CEP life cycle management
2. Evaluation and compilation of responses to Queries from Regulatory Agencies.
3. Proficient Knowledge of ICH Guidelines.
4.Candidate must have good drafting Skills in Framing the responses.
5.Knowledge of eCTD software and EU filing procedures is must
6. Reviewing documents like stability analytical Method Validation, Process Validation, Specification, Method of Analysis.
7. Compilation of QC Related data while preparing the Drug Master File.
8.Familiar with preparing SOPs related to Regulatory department.
Address:114, turf estate,, Dr. E Moses Road, Mahalakshmi, MUMBAI, Maharashtra, India
Selection Process: The selection will be on the basis of Interview.