Description Position: Sr. Regulatory Manager
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.
- 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
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