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

Jobs On The Way; Pune District; On-site; INR 600,000 - 840,000; Full time

Job summary

Jobs On The Way in Pune is seeking a Regulatory Affairs Executive – Francophone Markets with 3+ years in pharmaceutical regulatory work. You will compile CTD/ACTD dossiers (Modules 1–5), ensure compliance, and coordinate submissions for Francophone markets, while collaborating with QA/QC and Manufacturing teams.

Strong knowledge of CTD/ACTD documentation and experience in dossier submissions is essential. Freshers with regulatory exposure may apply; Bachelor's in Pharmacy is mandatory.

Qualifications

• B. Pharm degree is mandatory.
• 3+ years of pharma/regulatory experience; freshers with exposure may apply.
• Experience with CTD/ACTD documentation and international submissions.

Responsibilities

• Compile CTD/ACTD dossiers (Modules 1–5).
• Ensure regulatory compliance and documentation accuracy.
• Review dossiers prior to submission.
• Coordinate with QA, QC, and Manufacturing; external regulatory consultants.
• Manage submission timelines and trackers.

Skills

Regulatory experience

Dossier preparation

Regulatory submissions

Education

B. Pharm

Job description

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

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

• 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

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

Why Experience in Francophone Markets Is Valuable

Working with French-speaking regulatory authorities provides:

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

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

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.

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

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

International exposure significantly boosts salary growth and career opportunities