Posted:2 weeks ago| Platform: Naukri logo

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publishing compliance pharma formulation analytical strategic planning healthcare regulatory affairs senior executive regulatory affairs ich

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Work from Office

Job Type

Full Time

Job Description

Job Title:

Executive / Senior Executive - Regulatory Affairs (Formulation)

Location:

Pune, Maharashtra

Department:

Regulatory Affairs

Company:

SAVA Healthcare Limited

Job Purpose:

To manage the preparation, compilation, and submission of regulatory dossiers in compliance with international guidelines, with a focus on Europe (eCTD format) and Rest of the World (ROW) markets. The role ensures timely approvals and lifecycle management of pharmaceutical products.

Key Responsibilities:

Preparation and compilation of

dossiers in eCTD format

for European submissions (hands-on experience in eCTD is a must).
Sound understanding and working knowledge of

EU DCP/MRP procedures

.
Preparation and review of

regulatory dossiers for ROW markets

as per country-specific requirements.
Coordination with cross-functional teams to compile regulatory documentation in line with ICH and EU guidelines.
Preparation and submission of

variation and renewal packages

for approved products.

Responding to queries and deficiencies

raised by regulatory agencies within stipulated timelines.
Ensure compliance with current

ICH, EU, and national regulatory guidance documents

.
Support in regulatory strategy planning for new product submissions and lifecycle management.

Desired Candidate Profile:

Qualification:

B.Pharm / M.Pharm or equivalent in Pharmaceutical Sciences.

Experience:

2-5 years of relevant experience in Regulatory Affairs (formulation) with hands-on experience in eCTD submissions for Europe.

Skills Required:

  • Strong understanding of

    EU and ICH regulatory requirements

    .
  • Proficiency in

    eCTD publishing tools

    .
  • Good communication and documentation skills.
  • Detail-oriented with strong analytical and organizational abilities.

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Sava Healthcare Limited

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