Job Description

Mumbai, Andheri, Dombivli


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

Experience
2 - 4 Years

Salary
2 Lac 50 Thousand To 3 Lac 50 Thousand P.A.

Industry
Health Care / Pharmaceuticals / Medical

Qualification
Professional Degree, B.Pharma, B.Sc, M.Sc

Key Skills
Regulatory Affairs Executive



About Company


Contact Person
Kashinath Jha

Address
B 202, Bhavani Enclave Opp. Anand Old Age Home, New Satpati Road, Shirgaon, Palghar West

Mobile
9820032472

Email ID
doublehrconsultancy@gmail.com