Regulatory Affairs Executive jobs in Maharashtra - Double HR Consultancy

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