Regulatory Affairs Executive – Francophone Markets | Pune | B.Pharm | 3+ Years Experience

Are you searching for Regulatory Affairs Jobs in Pune with international exposure? 🌍

Here’s an exciting opportunity for experienced pharmaceutical professionals to work on Francophone (French-speaking) markets and build a strong global regulatory profile.

A reputed hiring firm in Pune is looking for a Regulatory Affairs Executive – Francophone Markets with experience in CTD/ACTD dossier preparation and international submissions.

If you have 3+ years of regulatory experience and strong documentation skills, this could be your next career breakthrough πŸš€


πŸ“Œ Job Overview

  • Position: Regulatory Affairs Executive – Francophone Markets
  • Location: Pune
  • Qualification: B. Pharm (Mandatory)
  • Experience: 3+ Years (Freshers with strong regulatory exposure may apply)
  • Industry: Pharmaceuticals / Nutraceuticals

🎯 Key Responsibilities

πŸ“‚ 1. CTD/ACTD Dossier Preparation

  • Compilation of CTD/ACTD dossiers (Modules 1–5)
  • Ensuring regulatory compliance and documentation accuracy
  • Reviewing dossiers prior to submission

🀝 2. Cross-Functional Coordination

  • Working closely with QA, QC, and Manufacturing teams
  • Coordinating with external regulatory consultants
  • Ensuring readiness of documentation within timelines

πŸ“Š 3. Regulatory Submissions & Tracking

  • Managing submission timelines for Francophone markets
  • Maintaining regulatory trackers and document archives
  • Ensuring proper submission record management

❓ 4. Handling Regulatory Queries

  • Responding to health authority queries
  • Submitting clarifications within deadlines
  • Ensuring continued compliance

🌍 Why Experience in Francophone Markets Is Valuable

Working with French-speaking regulatory authorities provides:

βœ” Global regulatory exposure
βœ” Expertise in international dossier management
βœ” Enhanced cross-border communication skills
βœ” Strong long-term career growth potential

Professionals with FF market experience are highly valued in multinational pharma companies 🌟


πŸŽ“ Eligibility Criteria

To apply for this Regulatory Affairs Executive role:

  • B. Pharm (Mandatory)
  • 3+ years of Pharma/Nutraceutical regulatory experience
  • Strong knowledge of CTD/ACTD documentation
  • Experience in dossier compilation and submissions
  • Ability to manage multiple timelines

✨ Freshers with internships or academic exposure in regulatory documentation may also apply.


πŸ’Ό Skills Preferred

  • Knowledge of global regulatory guidelines
  • Experience handling Module 1–5 documentation
  • Regulatory tracking tools proficiency
  • Strong analytical and documentation skills
  • Time management & deadline adherence

Bonus advantage if you’ve worked on international submissions 🌎


πŸ“ˆ Career Growth in Regulatory Affairs

Regulatory Affairs remains one of the most stable and high-demand domains in the pharmaceutical industry.

With experience, you can progress to roles such as:

  • Senior Regulatory Affairs Executive
  • Regulatory Affairs Manager
  • Global Regulatory Specialist
  • Dossier Management Lead

International exposure significantly boosts salary growth and career opportunities πŸ’‘


πŸ“© How to Apply?

Interested candidates can share their updated CV at:

πŸ“§ vishruti@hirecrest.in

Make sure your resume clearly highlights:

  • CTD/ACTD experience
  • Francophone or international market exposure
  • Submission handling experience
  • Regulatory query management

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