Unichem Laboratories Ltd is Hiring For Regulatory Affairs Manager and has issued notification to accept Applications.Promoted by the late Mr. Amrut Mody, a pioneer of the Indian pharmaceuticals business, Unichem Laboratories has grown to become one of India’s most respected pharmaceutical companies. It is committed to deliver better health through superior products. .Application form link provided at the end of post. Eligibility for the Multiple Position as follows.
Vacancy summary details :
- Company Name: Unichem Laboratories Ltd
- Location : Mumbai
- Post Name: Regulatory Affairs Manager
- Department: Regulatory Affairs
- Qualification: B.Pharma,M.pharma
- Experience: 4 – 6 years
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 31/01/2021
- Closing date for online Application : Apply as soon as possible
- Date of examination: NA
- Time and Venue :NA
- Mode of application : online
- Selection Process: Shortlisted candidates may called for selection process ( Personal interview , Group discussion , etc…,)
Job Description/Skills Required:
- Author high quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidances assuring technical congruency and regulatory compliance.
- Identify the required documentation for US regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical tre.
- Coordination with stakeholders on a regular basis to extend all technical support required from regulatory perspective.
- Actively participate as a member by contributing to the regulatory strategy, identifying critical issues and lessons learned.
- Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle.
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.