Hemmo Pharmaceuticals Pvt. Ltd is hiring in Regulatory Affairs.Hemmo Pharmaceuticals Pvt. Ltd. is India’s first & largest manufacturer of synthetic peptides. Hemmo Pharmaceuticals is privately held and has been in the business of peptides for the last 38+ years catering to the Pharmaceuticals, Research and Veterinary industries within India and globally.
Vacancy Details :
- Company Name: Hemmo Pharmaceuticals Pvt. Ltd
- Location : Navi Mumbai
- Post Name: Regulatory Affairs- Officer/Executive
- Department: Regulatory Affairs
- Qualification: MS/M.Sc(Science) /B.sc
- Experience: 4 to 6 years
- No of Vacancies: Details not provide by recruiter
- Details of Salary: ₹ 5,00,000 – 7,00,000 P.A.
- Contact: Mrs. Sneha Chavan/ 022-41552085
- Mode of application : Online
- Selection Process: Personal interview
Job Description/Skills Required :
1.Compilation and Filing of DMF in eCTD format for US, Europe, Canada and other markets as per
2. Responsible for DMF and CEP life cycle management.
3. Responsible for preparation of additional information or responses as requested by regulatory
4. Provide technical review of data or reports that will be incorporated into regulatory
submissions to assure scientific, accurate and clarity of presentation.
5. Proficient Knowledge of ICH Guidelines.
6. Conversant with FDA liaising and attending to License issues GMP Certificate, Additional
Product permission, COPP, FSC application etc.
Desired Candidate Profile
1. Good communication Skills
2. Time management.
3. Self motivated.
4. Preferred experience with API manufacturing company.