Glenmark Pharma is hiring for Regulatory Affairs – Assistant Manager (US Market).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.
Vacancy Details :
- Company Name: Glenmark Pharma
- Location : Navi Mumbai
- Post Name: Regulatory Affairs – Assistant Manager (US Market)
- Qualification: B.Pharm
- Experience: 7 – 9 years
- No of Vacancies: Details not provide by recruiter
- Details of Salary: Details not provide by recruiter
- Mode of application : Online
- Selection Process: Personal interview
Job Description/Skills Required :
- Compilation of ANDA dossier, deficiency response to FDA queries in eCTD format
- Strong review of Technical data required for ANDA compilation and deficiency response submission; Thorough DMF review & complete understanding of ICH guidelines and FDA guidances.
- Strong understanding of CMC, formulation development, Analytical Method Validation requirements and parameters included/stability/Photo stability and Forced degradation, etc.
- Knowledge w.r.t. OSD/Liquid Oral/Derma dosage forms is essential for this position
- Drafting of Controlled correspondence to the USFDA
- Support different stake holders for OSD, Oral liquid dosage forms and Derma by providing regulatory strategies.
- Impart training to CFTs for current FDA regulations and expectations w.r.t data requirement.
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
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