Job title: Regulatory Affairs Executive With finish formulation experience Job Location
Company:
Job description: .Regulatory Affairs Executive (With finish formulation experience ) Job Location
- 2 – 4 yrs
, , NA
Rs 2,50,000 to 3,50,000 p.a.
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- 58 Views
- Less than 5 Applicants
- 2022-08-20 2023-02-20
Job Description
Urgent Requirement
EXECUTIVE /MANAGER
REGULATORY AFFAIRS
With finish formulation experience.
Jobs Location: Dombivli (Thane) & Vile Parle (Mumbai) Maharashtra)
Position Title: Executive Regulatory Affairs
Industry Type: Pharmaceuticals/ Biotech
Employment Status: Permanent
Roles and Responsibilities
– New Registrations: Dossier Preparation Submission of dossiers either in the form of ACTD/CTD/
eCTD/regional formats as per the scheduled annual grid in ROW Markets.
Adopting the following process of:
Communication, procurement, review, compiling, and sharing of documents,
compliance, maintenance of additional data & backup.
Arranging of administrative documents for manufacturing facility products
(Manufacturing Lic, WHO-GMP, COPPs/FSC- Procuring and legalization), Samples, WS etc,
CDPs, artworks for complete ROW markets to facilitate filings as per the scheduled grids.
Coordination and follow-up with internal team and external agency for document process.
– Preparing dossiers as per the CTD/ country-specific requirement, Submitting dossiers to different
countries and Confirming that these dossiers are filed in the respective countries.
– Submission of Re-registration Dossiers in ROW markets.
– Submission of Query Responses raised by the health authority in a specific timeframe. Regulatory
Support with respect to providing the information for the facilitation of GMP inspection from various
Health Authorities.
– Maintain Database for registration status, deficiency states, amendments (if any) and
registration certificate. Review and approve exhibit batch /DGFT artworks.
– Arrangements of Administrative Documents Samples (FP/API) required for registration purposes
in ROW markets.
– Release of Registration Profile, Review and approval of change controls.
– Market Rest of World
Required Candidate Profile:
Education Required- B. PHARMA in Pharmacy & PHARMA in Pharmacy
Experience Required- Minimum 3 and more years of experience
Key Skills
Industry
Functional Area
Number of Vacancy
4
Qualification
Professional Degree, B.Pharma, B.Sc, M.Sc
About Double HR Consultancy
Double HR Consultancy is one of the most promising names in the placement sector of Palghar. We are actively involved in providing best-in-class placement services to various candidates & companies in the city. With our placement services, it has become possible for several candidates & organizations in making their future brighter. We offer a wide assortment of placement services such as work at home services, housekeeping services, corporate training services, HR consultancy services, placement consultancy services and career consultancy services.
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Expected salary: Rs.250000 – 350000 per year
Location: Thane, Maharashtra – Vile Parle, Maharashtra
Job date: Sat, 27 Aug 2022 04:00:22 GMT
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