Glenmark Pharma is hiring for Assistant Manager – Regulatory Affairs.Glenmark Pharmaceuticals Limited is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977.Application form link provided at the end of post. Eligibility for the Assistant Manager – Regulatory Affairs as follows.
Vacancy Details :
- Company Name: Glenmark Pharma
- Location : Navi Mumbai
- Post Name: Assistant Manager – Regulatory Affairs
- Department: Regulatory Affairs
- Qualification: B. Pharma, M.Pharma
- Experience: 7 – 9 years
- No of Vacancies: Details not provide by recruiter
- Details of Salary: Details not provide by recruiter
- Contact: NA
- Mode of application : Online
- Selection Process: Personal interview
Job Description/Skills Required :
A strong review of Technical data required for compilation of ANDA Compilation & submission
(i) API data: Thorough DMF review & complete understanding of ICH format/understand
intricacies of impurity profiling and impact, API-specifications and methods/detailed
understanding of AMV requirements and parameters included/stability/Photostability and
Forced degradation, etc.
(ii) FP data: Thorough review of FP data such as PDR/Process Validation/ understand intricacies
of impurity profiling of FP w.r.t. API & their impact, FP-specifications and methods/detailed
understanding of AMV requirements and parameters included/ stability/Photostability and
Forced degradation, etc.
(iii) Knowledge w.r.t. Respiratory (Inhalation Solution/Suspension, Nasal Spray, MDI, DPI)
products ANDA filing is essential
(iv) Regulatory ANDA filing strategy as per current FDA guidance
Support different stakeholders for Respiratory dosage forms by providing regulatory
strategies. Impart training to CFTs for current FDA regulations and expectations w.r.t data
requirement. Review and submit the Abbreviated New Drug Applications (ANDA) for US market
