Sr. Regulatory Manager - G432

Sr. Regulatory Manager - G432

21 Dec
|
INFINITY GROUP
|
Puri

21 Dec

INFINITY GROUP

Puri

Job Description



Description 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

The original job offer can be found in Kit Job:
https://www.kitjob.in/job/25758846/regulatory-manager-g432-puri/?utm_source=html

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:
Enter Your E-mail address to receive the latest job offers for: sr. regulatory manager - g432
Publish a new Free Offer
Need to publish an offer? With more than 1 million unique users per month, you will find the ideal candidate for your company instantly, what are you waiting for!
Publish Now

Subscribe to this job alert