Position: Sr. Regulatory Manager

Education:    
UG: B.Tech/B.E. - Bio-Chemistry/Bio-Technology, B.Sc - Any Specialization, Bio-Chemistry, Biology, Chemistry, B.Pharma - Pharmacy
PG: M.Tech - Bio-Chemistry/Bio-Technology, Biomedical, MS/M.Sc(Science) - Bio-Chemistry, Chemistry, M.Pharma - Pharmacy

Experience: 3-5 YEARS

Industry Type: Biotech / Clinical Research / Medical Device

Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Job Location: Vikas Puri, New Delhi

Number of working days: 06 days/week

Desired Candidate Skills:
- Regulatory Affairs, Documentation, DCGI, Liasoning, USFDA, CE, ISO, Dossiers
- Good communication skills.
- Handling DRA team.

Job Description:
-  Document preparation & compilation of registration dossiers as per the registration guidelines of each country.
-  Planning & preparing for renewal of registered products.
-  Coordination with plant for technical requirements for compilation of dossiers.
-  Managing the appropriate regulatory submissions & pre-market registration, & interact with authorities to obtain & maintain product approvals in USA, Europe, Canada & ROW market, 
-  Deep dive on QMS and see are there improvements required from RA perspective based on changes, amendments per new directives
-  Capable to provide guidance to the organization on the regulatory requirements for different regulatory countries.
-  Handling of Questionnaires of various customers & regulatory authorities.
-  Experience in DCGI,  Co-Ordination with MOH, Import Liasoning. local FDA Test license, DCGI Import/ export Licenses, 
-  Participation in regulatory audits from the US FDA and provide regulatory support 
-  External audit ISO 9001/13485
-  New CE Audit & CE audit -Surveillance 
-  Communicate and liaise with the site and the auditor for audit
-  New Product Development 
-  Resolve customer complaint, Fill customer complaint register, Prepare CAPA and risk assessment based upon the complaint, Close customer complaint
-  Coordinate with all the departments to complete tasks in a better way
-  Exposure in international regulatory audits such as CE, USFDA, WHO, ANVISA, EDQM.
-  Participate in technical discussions with clients as well as suppliers

Shift Timings: 10am -6pm

Age Limit: Upto 40 years

Salary Bracket: 10-12LPA

Gender Preference: Male

Company Profile: Hospital medical equipment manufacturer & wholesale supplier

Interested candidates please send your resume and photograph at srm.vpa@infinityjobs.in