Sun Pharmaceutical is hiring for Officer / Sr. Officer.From humble beginnings in 1983, Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India..Application form link provided at the end of post. Eligibility for the Regulatory Affairs Manager as follows.
Vacancy Details :
- Company Name: Sun Pharmaceutical
- Location : Vadodara
- PostName: Regulatory Affairs Manager
- Qualification: B.Pharma ,MS/M.Sc(Science) in Any Specialization,M.Pharma in Any Specialization
- Experience: 2-7 Years experienceÂ
- No of Vacancies: NA
- Details of Salary: NA
- Mode of application : Online
- Selection Process: Personal interview
- Contact : Rosemary.varghese@sunpharma.com.
Job Description/Skills Required :
Walk-in Interview – Regulatory Affairs – EM ( Formulation ) Baroda
Date : 29th May 2021 | Time : 10.00 am onwards
Mode of interview : Virtual
Send in your resumes to Rosemary.varghese@sunpharma.com.
Candidates who qualifies the requirement will be interviewed on call / video on 29th May 21
Qualification : B.Pharm / M.Pharm / PhD / M.Sc
Experience : 1 – 7 years
Grade : Sr Officer / Executive / Sr Executive
Job Summary
Regulatory submission of new products, variations, response to queries and Life cycle management for RU/CIS/Brazil/APAC/South Africa markets through preparation of quality dossiers enabling timely approvals.
Area Of Responsibility
1. New submissions:
a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
b. Review documents (Development report, scale up report, specification, stability protocol), artworks etc. before initiation of Exhibit batches for adequacy.
2. Approval :
Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
3. Lifecycle management for drug formulations:
a. Prepare and review variations as per the country requirements to support approval of changes such as API vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.
b. Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies.
4. Regulatory compliance:
a. Prepare, Review and circulate approval package to stake holders upon receipt of approval and update the same based on queries and variations.
b. Ensure reposition of comprehensive product information into central repository
C. Review regulatory filing impact of variations, change controls, etc.
Geographic Scope/ Market : RU/CIS/Brazil/APAC/South Africa
