HRD House is Hiring in Regulatory Affairs and has issued notification to accept Applications.Talent Search & Placements In Pharmaceutical, Nutraceuticals, OTC, Bulk Drugs and Chemical Companies at all levels & across the functions..Application form link provided at the end of post. Eligibility for the Regulatory Affairs Manager as follows.
Vacancy summary details :
- Company Name: HRD House
- Location :Mumbai
- Post Name: Regulatory Affairs Manager/ Executives
- Qualification: B.Pharma,M.pharma
- Experience: 5 – 10 years
- No of Vacancies: 04
- Details of Salary: ₹ 6,00,000 – 16,00,000 P.A.
- Opening date for online Application: 12/03/2021
- 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:
We are looking for Regulatory Affairs Managers / Executives (Total 4 position) to Work From Home for Pharma MNC Contract Research Labs working for European Market.
Candidates will be working from home on following 4 different areas (4 Different Position) and
will be reports to Head R&D Labs in Gujarat.
i) Regulatory Operations Executive/Manager
- To support the regulatory publishing and RIMS maintenance activities.
- Knowledge of submission publishing requirements in different formats such as NeeS and eCTD to support global submissions of Marketing Authorization Applications and life-cycle submissions.
- Support publishing activities and facilitate software bug troubleshooting.
ii) Regulatory Affairs Manager/ Senior Executive
- Regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
- The preparation of core dossiers and submissions for global roll out.
- Project strategy teams, develops and reviews global cross functional regulatory strategies.
iii) Regulatory Affairs Compliance Manager
- To support compliance of contract manufacturing sites in the validation and production.
- Review and/or approval of master manufacturing documentation.
- To provide timely and accurate review of master production records testing specifications and analytical methodology in accordance with the registered details. and completed batch records for validation batches from 3rd party manufacturers required for technical transfer related submissions.
iv) Regulatory Affairs Executive
- Provides operational regulatory support to project management on new divestment
- projects, technical transfer, CMOs, quality assurance and commercial departments.
- Coordinates and solicits components of the submission from various functional areas, distributors and CMOs.
- Proactively identifies project issues to the project team and supports mitigation plans.
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.