Sr. Regulatory Manager - G432

Sr. Regulatory Manager - G432

21 Dec

21 Dec



Job Description

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.

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

The original job offer can be found in Kit Job:

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