Regulatory Affairs Executive jobs in Maharashtra - Double HR Consultancy

Regulatory Affairs Executive jobs in Maharashtra

  • icon job experience 2 - 4 Years
  • icon job opening 4 Openings
  • icon salary Rs.2.50 - 3.50 Lakh/Yr
  • icon job location Maharashtra
  • icon job posting Posted 21 days ago

Key Skills

Regulatory Affairs

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

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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