Jubilant Life Sciences is Hiring for Regulatory Affairs Manager and has issued notification to accept Applications. Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. Interested and eligible candidates required to fill application form in online with Education and personal details and submit application along with resume .Job application form link provided at the end of post. Eligibility for the Regulatory Affairs Manager as follows.
Vacancy summary details :
- Company Name: Jubilant Life Sciences
- Location : Noida
- Post Name: Regulatory Affairs Manager
- Qualification: B.Pharma, M.Pharma, MS/M.Sc
- Experience: 6 – 11 years
- No of Vacancies: 02
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application:03/05/2021
- 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:
- Provides regulatory expertise and requirements to other departments during product development or for changes proposed to approved products (including R & D, Manufacturing, Quality Assurance, Quality Control, Marketing and Clinical Affairs)
- Prepares pharmaceutical and technical documentation for new drug submission or abbreviated drug submission to obtain approval for clinical trials, for marketing the product and for updating application for marketed products
- Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration
- Prepares, reviews, analyzes and consolidates all information required for initial or post-approval regulatory submissions with relevant authorities including European Agencies, USFDA, Health Canada and international regulations;
- Writes the pharmaceutical and related technical portions of Comprehensive Summaries that are included in the drug submission filed to Regulatory Agencies.
- Participate in the elaboration of the product labelling for the targeted countries.
- Prepare computer-based submission summaries
- Ensures compliance with government regulations by providing Regulatory Agencies with all necessary information relating to changes or modifications of the company’s products
- Reviews technical and clinical documentation and may recommend changes in labeling, manufacturing, marketing, and clinical protocols in order to ensure and maintain regulatory compliance
- Assist with the preparation of departmental standard operating procedures (SOPs).
- Provide other regulatory support for regulatory compliance activities as required.
- Maintain professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in the field of expertise.
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.